[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"estrogen-receptor-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:estrogen-receptor-positive-breast-cancer":251},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,80,108,131,170,198,237,264,297,325],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100520894","phase-2-elacestrant-vs-elacestrant-plus-a-cdk46-inhibitor-in-patients-with-erpositiveher2-negative-advanced-or-metastatic-breast-cancer-100520894",false,"NCT06062498","Elacestrant vs Elacestrant Plus a CDK4\u002F6 Inhibitor in Patients With ERpositive\u002FHER2-negative Advanced or Metastatic Breast Cancer","Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4\u002F6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+\u002FHER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4\u002F6 Inhibitor","Inclusion Criteria All Arms:\n\n* Patients must have histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines (Allison et al, 2020, Wolff et al, 2018).\n\nNote: In the context of this trial, ER status will be considered positive if \\>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry. Note: Fresh biopsy is not a requirement.\n\n* Patients must have a confirmed ESR1 mutation. Note: This information will be drawn from patients' treatment charts. Mutational analysis will be done as standard of care; there is no research-related mutational testing for this study. ctDNA may be used for mutational testing.\n* Patients must have at least one measurable lesion (as per RECIST v1.1) lesion anywhere in the body or a mainly lytic metastatic bone lesion. Note: Lytic bone lesions with identifiable soft tissue components that can be evaluated by cross-sectional imaging techniques such as CT or MRI can be considered as measurable lesions if the soft tissue component meets the definition of measurability per RECIST v1.1.\n* Patients must have received at least 2 prior endocrine therapies, including a CDK4\u002F6 inhibitor in the metastatic disease setting.\n* Patients must be age ≥ 18 years. Patients of childbearing potential (POCBP) may be premenopausal, postmenopausal, or perimenopausal.\n* Potential POCBP who may be menopausal and are \\\u003C 55 years of age must have a serum follicle-stimulating hormone (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n* Patients must exhibit an ECOG performance status of 0 or 1.\n* Patients must have adequate organ and bone marrow function as defined below:\n\nLeukocytes (WBC) ≥ 3,000\u002FmcL Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL Hemoglobin (Hgb) ≥ 80-100 g\u002FdL Platelets (PLT) ≥ 50,000\u002FmcL Total serum bilirubin \\\u003C 1.5 x Institutional upper limit of normal (ULN) AST (SGOT) ≤ 3 x institutional ULN (no liver metastases)\n\n* 5 x institutional ULN (liver metastases present) ALT (SGPT) ≤ 3 x institutional ULN\n* 5 x institutional ULN (liver metastases present) Cockcroft-Gault based creatinine clearance\n\n  * 50 mL\u002Fmin\n\nNote:\n\n* Creatinine clearance (DMAB)\n\n  = (\\[140-age in years\\] × weight in kg)\u002F (\\[serum creatinine in mg\u002FdL\\] × 72)\n* Creatinine clearance (DFAB) = (0.85 × \\[140-age in years\\] × weight in kg)\u002F (\\[serum creatinine in mg\u002FdL\\] × 72) Note: Growth factor\u002Ftransfusion support to attain these levels is not permitted.\n\n  * For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.\n  * For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are eligible.\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Elacestrant is a known teratogen. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception (see Appendix B) from time of informed consent, for the duration of study participation, and for 7 days following completion of elacestrant therapy.\n\nShould a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 7 days after completion of administration. Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months) Note: POCBP who are on combination therapy with any study CKD4\u002F6 inhibitor (palbociclib, abemaciclib, or ribociclib) must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 21 days following completion of CKD4\u002F6 inhibitor therapy. POCBP must have a negative pregnancy test prior to registration on study. If initial urine pregnancy test is positive or cannot be confirmed negative, serum pregnancy test will be required. -Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nInclusion Criteria - Combination Therapy Arm 2 with Palbociclib, Abemaciclib, or Ribociclib\n\n-Patients who have been treated with one or two prior hormonal therapies in the metastatic setting if at least one hormonal therapy was in combination with a CDK4\u002F6 inhibitor.\n\nNotes:\n\n* Patients who are already on or have already been exposed to one or two of the study CDK4\u002F6 inhibitors at registration will be assigned a different study CDK4\u002F6 inhibitor (e.g., if a patient has already been exposed to abemaciclib, they will be given ribociclib or palbociclib; similarly, if a patient has already been exposed to palbociclib and abemaciclib, they will be given ribociclib.)\n* One-to-one randomization will be done by the QA team once patients have been registered.\n\nExclusion Criteria All Arms:\n\n* Patients who have received prior elacestrant.\n* Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration.\n* Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment.\n* Patients with brain metastases. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for brain management for at least 4 weeks before starting treatment in this study. The dose must be \\\u003C2.0 mg\u002Fday of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. RANO criteria are used to evaluate brain metastases\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 3) with the exception of alopecia.\n* Patients who are receiving any other investigational agents. For patients who were previously on palbociclib, abemaciclib, or ribociclib, the washout period between stopping that CDK4\u002F6 inhibitor and starting a different one is 14 days.\n* Patients with advanced, symptomatic visceral spread who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \\>50%.\n* Patients with documented pneumonitis\u002Finterstitial lung disease prior to registration.\n* Patients who have received major surgery within 28 days before starting trial therapy.\n* Patients who are taking strong or moderate CYP3A4 inducers or strong or moderate CYP3A4 inhibitors. See Section 4.4 for additional incompatibilities.\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant. Note: Refer to exclusion criteria below for eligibility criteria related to study CDK4\u002F6 inhibitors.\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Hypertension that is not controlled on medication\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients with refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection or gastric bypass surgery), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug. Similarly, patients who are unable to take\u002Fretain oral medications.","ALL","18 Years",{"count":19,"type":20},174,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting.\n\nThe purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4\u002F6 inhibitor to treat patients with ER+\u002FHER2- or metastatic breast cancer with prior exposure to a CDK4\u002F6 inhibitor.",[26,27,28,29],"Estrogen-receptor-positive Breast Cancer","HER2\u002FNeu-Negative Breast Cancer","Advanced Breast Cancerv","Metastatic Breast Cancer","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2023-09-29",{"date":38,"type":20},"2029-07-01",{"name":40,"class":41},"Northwestern University","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100610025","phase-2-phii-randomized-capecitabine--elacestrant-vs-capecitabine-alone-in-er-breast-cancer-capela-100610025","NCT07222215","PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)","A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)","CAPELA","Inclusion Criteria:\n\n* Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer. ER and HER2 measurements should be performed according to institutional guidelines in a CLIA-approved setting. ER must be ≥ 10% on the most recent biopsy in which receptor testing was performed. Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.\n* Participants must have standard of care ctDNA sequencing testing documenting ESR1 and TP53 mutation status. In patients without ESR1 mutation, this result must be from within 3 months.\n\n  * ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G\n  * TP53 mutations that are considered pathogenic as determined by a CLIA certified laboratory\n* Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with elacestrant participants \\\u003C18 years of age are excluded from this study\n* Women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women who have been on a GnRH agonist for at least three consecutive months prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy or total hysterectomy after adequate healing post-surgery\n* Must have measurable or evaluable disease by RECIST 1.1. Must have progressed on at least one line of endocrine therapy in the metastatic setting or recurred on or within one year of adjuvant endocrine therapy\n* Unrestricted number of prior endocrine therapies (with or without targeted treatment) are allowed in the advanced disease setting. If a patient recurred on or within one year of adjuvant endocrine therapy, it would be counted as one line of treatment.\n* Prior CDK4\u002F6 inhibition is required (in adjuvant or metastatic disease), unless a CDK4\u002F6 inhibitor is contraindicated (CDK4\u002F6 inhibitor in combination with endocrine treatment is considered as one line of endocrine treatment).\n* Participants must have remained on a prior endocrine treatment alone or in combination with a CDK4\u002F6 inhibitor in the metastatic setting without progression for at least 6 months prior to study entry. This regimen does not need to be the most recent regimen prior to study entry. If patients have progressed on adjuvant endocrine treatment and have not received treatment in the metastatic setting, they must have progressed after at least two years of adjuvant endocrine treatments.\n* Prior alpelisib with endocrine treatment is allowed (considered as a line of endocrine treatment).\n* Prior everolimus with endocrine treatment is allowed (considered a line of endocrine treatment).\n* Prior capivasertib with endocrine treatment is allowed (considered a line of endocrine treatment)\n* Prior fulvestrant is permitted. Prior SERM (tamoxifen, lasofoxifene) is permitted. Neither prior oral SERDs nor other next generation oral endocrine therapies (such as PROTACS) are permitted.\n* No prior chemotherapy regimen or ADC is allowed in the metastatic setting.\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing grade \\>1 treatment-related toxicities at study entry and must have completed treatment \\> 14 days prior to registration.\n* ECOG PS 0-1\n* Adequate hematological, liver, and kidney function, as defined below:\n\n  * Absolute neutrophil count \\> 1,500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin \\> 9 g\u002FdL (transfusion is allowed to meet this criterion) Total bilirubin \\\u003C 1.5 x institutional upper limit or normal (ULN) or \\\u003C 3 institutional ULN in the presence of documented Gilbert's syndrome\n  * AST (SGOT)\u002FALT (SGPT) \\\u003C 2.5 x institutional ULN, or ≤ 5 institutional ULN for subjects with documented metastatic disease to the liver\n  * Creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m2\n* Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of capecitabine.\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are:\n\n  * Age \\> 60 years; or\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) and FSH levels are within postmenopausal range; or\n  * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates.\n\nNote: No HIV testing is required at screening unless mandated by local health Authority.\n\n* Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation.\n\nNote: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.Hepatitis B screening tests are not required unless:\n\n* Known history of HBV infection\n* As mandated by local health authority Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before allocation.\n\nHepatitis C screening tests are not required unless:\n\n* Known history of HCV infection\n* As mandated by local health authority\n\nExclusion Criteria:\n\n* Participants who have had endocrine and\u002For biologic therapy \\\u003C 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1; alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 toxicity not constituting a safety risk based on investigator's judgment are acceptable). This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Participants who are receiving concurrent therapy with other investigational agents. This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term. It is likely that these patients will not benefit from this regimen.\n* History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.\n* Participants with active brain metastases. Treated brain metastases that are asymptomatic and do not require systemic steroids for management of symptoms are allowed if they have received SRS (7-day washout) or WBRT (14-day washout) or asymptomatic untreated brain metastases measuring \\\u003C1cm. Patients with leptomeningeal disease are not eligible. It is unlikely that these patients will benefit from this regimen.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. This could increase risk of toxicity from treatment and potentially decrease adherence to study protocol.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * (1) Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. These cases should be discussed with the sponsor-investigator prior to enrollment.\n  * (2) Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. History of prior malignancy puts patients at risk of recurrence from their prior malignancy or progression of a second malignancy which would complicate interpretation of the end points of this trial.\n* Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (dabigatran, digoxin, fexofenadine) or BRCP (rosuvastatin, sulfasalazine). These drugs have potential drug-drug interactions with the study agents.\n* Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced.\n* Medical conditions requiring concomitant administration of medications with a narrow therapeutic window metabolized by CYP3A and for which a dose reduction cannot be considered. See Appendix D for a list of medications that are CYP3A substrates. These drugs have potential drug-drug interactions with the study agents.\n* Female participants lactating or nursing. The safety of these medications in pregnancy or breast feeding patients is unknown.\n\nBoth men and women of all races and ethnic groups are eligible for this trial.",{"count":52,"type":20},297,[23],"The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4\u002F6 inhibitors, including palbociclib, ribociclib, or abemaciclb.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Capecitabine (a type of fluoropyrimidine antimetabolite)",[26,29,56,57,58,59,60,61,62],"Breast Cancer","Hormone Receptor Positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","HER2- Breast Cancer","ESR1 Gene Mutation","ER Wildtype","Breast Neoplasms",[64,29,65,66,67,59,68,69],"Advanced Estrogen Receptor-Positive Breast Cancer","Breast cancer","Hormone receptor positive breast cancer","Advanced Human Epidermal Growth Factor Receptor 2 negative breast cancer","ESR1 gene mutation","ER wildtype","2026-06-10",{"date":72,"type":34},"2026-06-12",{"date":74,"type":34},"2026-01-16",{"date":76,"type":20},"2030-10-01",{"name":78,"class":41},"Kristina A. Fanucci",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100619124","phase-2-evolutionary-clinical-trial-for-novel-biomarker-driven-therapies-100619124","NCT07340541","Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies","TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)","EVOLVE-BDT","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years of age at the time of consent\n* ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).\n* Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol\n\nExclusion Criteria:\n\n* Inaccessible metastatic lesion to research biopsy\n* Subject has already initiated 2nd line therapy\n* Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation",{"count":89,"type":20},700,[23],"This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive\u002Fhormone receptor-negative (ER+\u002FHR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.",[56,29,93,26,94],"Triple Negative Breast Cancer","Hormone Receptor Negative Breast Carcinoma",[96,97],"biomarker directed therapies","biomarker stratified trial","2026-05-19",{"date":100,"type":34},"2026-05-20",{"date":102,"type":34},"2026-02-16",{"date":104,"type":20},"2031-06-02",{"name":106,"class":41},"UNC Lineberger Comprehensive Cancer Center",2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":79},"100556489","phase-2-adaptive-therapy-with-capecitabine-for-treatment-of-metastatic-er-positive-her2-negative-breast-cancer-100556489","NCT06525766","Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer","Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines, metastatic breast cancer\n* Measurable disease. Bone only disease allowed if associated with soft tissue component that is measurable by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 14 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Ability to undergo re-staging CT scans as required by the protocol\n* Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Prior chemotherapy or use of antibody drug conjugate in the metastatic setting\n* Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any of the following prior therapies:\n\n  * Major surgery ≤ 3 weeks prior to registration\n  * Radiation therapy ≤ 2 weeks prior to registration\n* Evidence of visceral crisis or impending cord compression\n* Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * uncontrolled cardiac arrhythmia\n  * chronic oxygen dependence\n  * respiratory failure\n  * or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n* If there is a history of prior malignancy, they must not be receiving other cancer specific treatment. Except for antiestrogen treatment (aromatase inhibitors or selective estrogen modulators) for their cancer are permitted if they meet other eligibility criteria. Denosumab and zoledronic acid, are permitted as established adjunct therapies per guidelines\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity\n* History of severe hypersensitivity reactions to fluorouracil or capecitabine",{"count":116,"type":20},35,[23],"This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.",[120,26,121,29],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic HER2-Negative Breast Carcinoma","2026-05-08",{"date":124,"type":34},"2026-05-11",{"date":126,"type":34},"2025-10-01",{"date":128,"type":20},"2030-10-15",{"name":130,"class":41},"Mayo Clinic",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":139,"minAge":4,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":150,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":107},"100631386","phase-2-randomized-double-blind-phase-ii-trial-of-baby-exemestane-versus-baby-tamoxifen-in-post-menopausal-women-at-high-risk-for-breast-cancer-100631386","NCT07499999","Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer","Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer (BabyTEARS)","BabyTEARS","Inclusion Criteria:\n\n* Postmenopausal state is defined⁸ as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.\n* Any of the following criteria must be met:\n\n  * Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (\\>5%) DCIS (patients with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy (see footnote 1 below)) diagnosis within 3 years of HRL (ADH, LCIS, ALH), or;\n  * At least 3% breast cancer risk at 5 years (or 5% risk at 10yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 or Tyrer-Cuzick model V8 or;\n  * Known carriers of a germline pathogenic\u002Flikely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years\n* Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1\n* Able to swallow oral medications\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Specifically, all cancers diagnosed since 3 years or longer except for breast and endometrial are eligible.\n* Ability to understand and the willingness to sign a written informed consent document\n* Mammography performed up to 6 months before the trial consent form signature\n* DEXA performed up to 12 months before the trial consent form signature\n* Life expectancy ≥ 10 years\n* Normal liver function tests and blood cell count\n* Negative gynecological examination performed up to 6 months before the trial consent form signature.\n\nᶥ While DCIS and ADH are routinely excised, and treatment of DCIS often includes radiotherapy, lobular neoplasia (ALH and classic LCIS) are not routinely excised in most US centers unless radiologic-pathologic findings are discordant given the very low risk of an associated cancer.11,12 Participants with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy. All DCIS will require excision to clear margins per the SSO\u002FASCO\u002FASTRO margin guidelines for DCIS.88 In selected cases, the decision to omit RT might be taken according to low risk clinical-pathological factors (e.g., age\\>70, low grade, size \\\u003C 1 cm, and genomic assays if available) as well as patient preference after full discussion of the risks and benefits.\n\nExclusion Criteria:\n\n* Pre\u002Fperimenopausal women: exemestane is only effective in post-menopausal women\n* History of DVT or PE: tamoxifen can increase tendency to blood clot\n* Endometrial cancer: full-dose tamoxifen is associated with increased risk of endometrial cancers\n* Macular disorders: tamoxifen is associated with retinal damage\n* Inability to comply with study procedures: standard\n* Prior use of antiestrogens within 12 months from the date of the trial consent form signature: there can be long duration effects from antiestrogens that could influence trial drug effects\n* Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature: similarly, wish to avoid any long lasting effect before alternate effect from study drugs\n* Severe osteoporosis (T score ≤ 2.5 at either spine or hip), or recent vertebral fracture (within 6 months) not treated with zoledronic acid or denosumab: Exemestane is an aromatase inhibitor which can worsen bone loss (osteoporosis)\n* Current use of terbinafine, quinidine, cinacalcet, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort, warfarin, erythromycin, cyclosporin, nifedipine and any concomitant coumarin-type anti-coagulant therapy: these drugs compete for the Cytochrome P450 metabolic pathways of tamoxifen and exemestane\n* Moderate or severe renal impairment: Exemestane is eliminated equally by liver and renal metabolism\n* Known hypersensitivity to study drugs: standard\n\nScreening Eligibility Criteria\n\nTo register a participant to the screening phase, the following documents should be provided by the participating site:\n\nSigned participant consent form\n\n* Postmenopausal status, and any of the following:\n\n  * Histological report of ER-positive DCIS within 12 months, or HRL of the breast within 3 years from date of consent form signature, or;\n  * Report of risk assessment ≥3% in 5 years or 5% in 10 years of breast cancer according to the selected risk model(s) different criteria within 6 months from screening, or;\n  * Documentation of women carriers of a germline pathogenic\u002Flikely pathogenetic variant in a moderate penetrance gene (CHEK2 or ATM), or;\n  * Documented history of chest wall radiotherapy before age 30.\n* Inclusion of Women and Minorities\n\nOnly women will be recruited in the study given that breast cancer is much more frequent in women than men and because exemestane is contraindicated in men because of risk of uncontrolled gonadal stimulation. Women of all races and ethnic groups are eligible for this trial. At participating sites, efforts will be made to enroll women from diverse ethnic and socio-economic backgrounds, including recruitment of non-white women in a selected New York city area.\n\nNIH policy requires that women and members of minority groups and their subpopulations be included in all NIH-supported biomedical and behavioral research projects involving NIH-defined clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the funding Institute \\& Center (IC) Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances designated by the Director, NIH, upon the recommendation of an IC Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research.","FEMALE",{"count":141,"type":20},140,[23],"The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Exemestane (a type of steroidal aromatase inhibitor)\n* Tamoxifen (a type of selective estrogen receptor modulator)",[56,145,26,146,147,148,149],"Ductal Carcinoma","Atypical Lobular Hyperplasia","BRCA2 Mutation","CHEK2 Gene Mutation","Ataxia Telangiectasia Mutated Gene Mutation",[56,151,152,153,154,155,156,146,157,158,159],"High Risk Breast Cancer","Cancer Prevention","Ductual Carcinoma in Site","Estrogen Receptor Positive","High Risk Lesions","HRL","BRCA2","CHEK2","ATM","NOT_YET_RECRUITING","2026-03-24",{"date":163,"type":34},"2026-03-30",{"date":165,"type":20},"2026-09-09",{"date":167,"type":20},"2028-08-31",{"name":169,"class":41},"Dana-Farber Cancer Institute",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":139,"minAge":178,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":107},"100582759","breast-re-irradiation-after-second-ipsilateral-lumpectomy-100582759","NCT06867484","Breast Re-irradiation After Second Ipsilateral Lumpectomy","Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)","BRASIL","Inclusion Criteria:\n\n* Diagnosed with ER+HER2- breast cancer\n* Provision of signed and dated ICF\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age ≥ 40 years\n* Oncotype \\\u003C 26 (postmenopausal) \\\u003C16 (premenopausal), Low, or Ultra-Low index.\n* Minimum interval of 18 months from last breast radiotherapy session.\n* Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available.\n* Ipsilateral recurrence, unifocal \\\u003C 3 cm with negative margins, N0, Tis and invasive (pathological staging)\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Planning target volume: whole breast (PTV: WB) ratio \\\u003C 1\u002F2\n* Life expectancy \\> 12 months\n* Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.\n\nA person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)\n\nExclusion Criteria:\n\n* BRCA1\u002F2 mutation or any other receptor subtypes\n* Individuals assigned male at birth with breast cancer\n* Pregnancy or breastfeeding\n* Skin involvement\n* Distant metastasis\n* Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms.\n* Other malignancies (except skin)\n* Connective tissue disorder (e.g., scleroderma, lupus)\n* Any other condition that may put a participant at higher risk, at the discretion of the investigator.","40 Years",{"count":180,"type":20},114,[182],"NA","The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.",[56,185,186,187,188,26],"Cancer","Cancer of the Breast","HER2-negative Breast Cancer","ER+ Breast Cancer","2025-11-12",{"date":191,"type":34},"2025-11-13",{"date":193,"type":34},"2025-10-27",{"date":195,"type":20},"2033-05",{"name":197,"class":41},"Youssef Zeidan",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":236},"100485894","phase-2-z-endoxifen-for-the-treatment-of-premenopausal-women-with-erher2--breast-cancer-100485894","NCT05607004","(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+\u002FHER2- Breast Cancer","A Phase 2 Trial of (Z)-Endoxifen + Goserelin as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Breast Cancer","EVANGELINE","Inclusion Criteria:\n\n1. Female sex assigned at birth. Female to male transgender individuals who have not had any hormonal therapy may be considered for the trial after review and approval from the medical monitor and study sponsor.\n2. Age 18 years or older\n3. Not lactating, pregnant, or planning to become pregnant in the next year and agrees to take adequate steps to prevent becoming pregnant beginning at informed consent, during treatment and for 9 months after last dose and agree to not breast feed during treatment and for 3 months after last dose.\n4. Must agree to use at least one non-hormonal highly effective method of contraception for the entire duration of study participation beginning at informed consent. Highly effective methods of birth control are defined as those, alone or in combination, that resulted in a low failure rate of \\\u003C1% per year when used consistently and correctly such as intrauterine devices (IUDs, non-hormonal such as copper IUD), bilateral tubal occlusion, sexual abstinence or vasectomized partner\n5. Premenopausal defined as any female who:\n\n   1. is menstruating or\n   2. is not menstruating (last menstrual period \\> 3 months prior to registration) but has a plasma estradiol in the premenopausal range as assessed locally\n6. Pathologic confirmation of strongly estrogen receptor positive (ER+) (defined as estrogen receptor \\[ER\\] ≥ 67% or Allred Score 6-8) by local institution protocol\n7. Eastern Cooperative Oncology Group ECOG Performance Status (ECOG PS) of 0 to 2\n8. Nottingham (Elston-Ellis) Grade 1 or 2\n9. HER2- breast cancer (histologically confirmed) using American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines\n10. Clinical T2 or T3 invasive breast cancer (per American Joint Committee on Cancer \\[AJCC\\] 8th edition clinical staging)\n11. Clinical N0 or N1 invasive breast cancer (per American Joint Committee on Cancer \\[AJCC\\] 8th edition clinical staging)\n12. MRI ≤ 35 days of registration\n13. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects\n14. Willing to provide blood and breast tissue samples for research purposes at specified timepoints for the duration of their participation in the trial.\n\nExclusion Criteria:\n\n1. Bilateral invasive breast cancer; Inflammatory breast cancer defined as clinically significant erythema of the breast and\u002For documented dermal lymphatic invasion or bilateral invasive breast cancer (patients with pre-malignant disease or DCIS\u002FLCIS in contralateral breast are eligible)\n2. Prior diagnosis or treatment for breast cancer, including carcinoma in situ, or history of any other active malignancy within the past 2 years prior to study entry with the exception of:\n\n   1. Adequately treated in situ carcinoma of the cervix uteri\n   2. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin\n   3. Any other malignancy with a life expectancy of less than 2 years\n3. Any uncontrolled intercurrent illness including, but not limited to:\n\n   1. Ongoing or active infection requiring systemic treatment with strong inhibitors\u002Finducers of CYP450 enzymes (including bacterial infection, fungal infection, or detectable viral infection).\n   2. Symptomatic congestive heart failure,\n   3. Unstable angina pectoris,\n   4. Uncontrolled symptomatic cardiac arrhythmias\n   5. Uncontrolled hypertension\n   6. Uncontrolled diabetes (Hemoglobin A1c \\[HbA1c\\] \\>7%)\n   7. Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 470 milliseconds \\[msec\\]) using Fridericia's QT correction formula seen ≤ 28 days of registration\n4. Any of the following co-morbid conditions:\n\n   1. Known cataracts or retinopathy\n   2. History of deep vein thrombosis (DVT)\u002Fpulmonary embolism (PE)\n   3. Known activated protein C (APC) resistance, an inherited coagulation disorder\n   4. End stage kidney disease requiring dialysis\n5. Evidence of the following laboratory abnormalities ≤ 28 days prior to registration:\n\n   1. Total bilirubin ≥ 1.5 x upper limit of normal (ULN)\n   2. Aspartate aminotransferase (AST) or alanine amino transferase (ALT) ≥ 2.5 x ULN\n   3. Platelet count (PLT) ≤ 75,000\u002Fmm3\n   4. Hemoglobin (Hb) ≤ 10 g\u002FdL\n6. Hormonal therapies including birth control and hormone replacement therapy, or prior use of androgen-based therapy during the study or within 1 week of registration. If subject has a prior medical history of Depo-Provera®, it is recommended that the last dose of 3-month contraceptive agents are \\> 2.5 months from registration.\n7. Allergy to endoxifen, goserelin, or exemestane or any of their components\n8. Participation in another investigational clinical trial ≤ 6 months of registration\n9. Known metastatic disease",{"count":207,"type":20},87,[23],"This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+\u002FHER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or \"SERM\", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.\n\nThe PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50\u002F50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.\n\nThe Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\\>10%.\n\nA key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.\n\nStudy participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.",[62,211,26,187],"Invasive Breast Cancer",[213,214,215,216,217,218,219,220,221,222,223,224,225],"breast cancer","ER+\u002FHER2-","endocrine therapy","neoadjuvant","(Z)-endoxifen","exemestane","goserelin","Ki-67","estrogen receptor negative","human epidermal growth factor receptor 2 negative","Stage II","tamoxifen","PKCB1","2025-10-29",{"date":228,"type":34},"2025-10-30",{"date":230,"type":34},"2023-02-14",{"date":232,"type":20},"2027-04",{"name":234,"class":235},"Atossa Therapeutics, Inc.","INDUSTRY",15,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":254,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":79},"100549871","phase-2-the-sappho-study-sequential-therapy-with-curative-intent-in-de-novo-her2-metastatic-breast-cancer-100549871","NCT06439693","The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer","A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study","Inclusion criteria:\n\n* Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo metastatic) with unequivocal evidence of metastasis on imaging.\n* Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines. HER2 status must be determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory (central testing not required). Patients with HER2 1+ or 2+ disease which is HER2 FISH positive are not eligible to enroll.\n* No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab\u002Fpertuzumab\u002Ftaxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or non-cancerous lesions is allowed if it has been completed at least 5 years prior to study entry.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \\<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before starting THP for patients who start metastatic therapy prior to study entry.\n* Participants must meet the following organ and marrow function as defined below within 28 days prior to registration:\n\n  * Hgb ≥9.0 g\u002FdL\n  * Absolute Neutrophil Count ≥ 1,000 \u002Fmm3\n  * Platelets ≥100,000\u002Fmm3\n  * Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\\'s syndrome.\n  * AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases\n  * Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL\u002Fmin\n* Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met:\n\n  * CD4+ T-cell (CD4+) counts \\> 350 cells\u002FuL\n  * No history of AIDS-defining opportunistic infection within 12 months prior to enrollments\n  * Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen.\n* Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and are not on a medication with a known interaction with the agents used in the study treatment regimen. The following guidance applies:\n\n  * patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.\n  * patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification.\n  * patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.\n* Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met:\n\n  * Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry.\n  * Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are eligible if time from local therapy and first dose of study treatment is:\n\n    * 7 days for stereotactic radiosurgery (SRS);\n    * 14 days for whole-brain radiation therapy (WBRT);\n    * 28 days for surgical resection.\n  * Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic treatment can be interrupted as determined by the treating physician and after discussion with the Sponsor Investigator.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible (i.e., adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer).\n* This study involves agents that have known genotoxic, mutagenic and teratogenic effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her Partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study therapy.\n* Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months or who have been on ovarian suppression in the past year.\n* Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion criteria:\n\n* Prior history of invasive breast carcinoma\n* Treatment with any other investigational agents for this condition.\n* Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study.\n* Extracranial palliative radiotherapy within 7 days prior to enrollment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib.\n* Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).\n* Subjects must not have any of the following:\n\n  * Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>2 mg of dexamethasone (or equivalent).\n  * Known or concurrent leptomeningeal disease on screening MRI\n  * Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures\n* History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Sponsor-Investigator.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* History of other lung disease, such as:\n\n  * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion etc.).\n  * Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  * Prior pneumonectomy.\n* Active or uncontrolled clinically serious infection\n* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have ongoing ≥ Grade 2 diarrhea of any etiology\n* Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and\u002For CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.\n* Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued prior to enrollment.",{"count":245,"type":20},72,[23],"The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.\n\nThe names of the study drugs involved in this study are:\n\n* Paclitaxel (a type of anti-microtubule agent)\n* Docetaxel (a type of anti-microtubule agent)\n* Nab-Paclitaxel (a type of anti-microtubule agent)\n* Trastuzumab (a type of IgG1 kappa monoclonal antibody)\n* Pertuzumab (a type of monoclonal antibody)\n* Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)\n* Tucatinib (Tyrosine Kinase HER2 Inhibitor)\n* Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)",[249,56,250,251,252,253],"Breast Cancer Female","Breast Cancer Metastatic","Estrogen Receptor-positive Breast Cancer","HER2-positive Breast Cancer","Stage IV Breast Cancer",[56,249,250,255,252,253],"Estrogen Receptor-Positive Breast Cancer","2025-06-23",{"date":258,"type":34},"2025-06-26",{"date":260,"type":34},"2024-08-08",{"date":262,"type":20},"2033-03-30",{"name":169,"class":41},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":79},"100527679","phase-2-ketorolac-and-pregabalin-effects-on-breast-cancer-keprest-100527679","NCT06150898","Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)","Unravelling the Local and Systemic Effects of Primary Surgery and Perioperative Use of Ketorolac and Pregabalin in Primary Breast Cancer Patients According to Adiposity","KePreSt","Inclusion Criteria:\n\nSubjects must meet all of the following criteria in order to be eligible for this study:\n\n1. Age ≥ 18 years and ≤ 70 years old\n2. Female\n3. Weight ≥ 35 kg\n4. Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing with ER-positive is defined as having an immunohistochemistry (IHC) of 1% or more and\u002For Allred score of 3 or more\n5. Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI\u002FCT scan.\n6. Stage I, II or III disease (non-metastatic)\n7. In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to local testing\n8. Subject scheduled for a primary breast cancer surgery\n9. Subject is willing to provide plasma\u002Fblood and tumour samples for translational research.\n10. Subject is willing to provide tissue from a newly obtained core or excisional biopsy of the tumour that should be evaluable for central histological characterization and future molecular testing\n11. Subject is willing to take omeprazole and has no contraindication to omeprazole.\n12. Have an HEMSTOP score\\\u003C2 and conventional coagulation screening test within normal limits such as activated partial thromboplastin time (21.6\\\u003C aPTT \\>28.7), international normalised ratio (1.31\\\u003CINR) and platelet count (\\>100.10³\u002Fml)\n13. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least one months after the last administration of study treatment.\n14. Negative serum pregnancy test for women of childbearing potential (within 30 days before start of treatment)\n15. Subject is willing and able to provide written informed consent for the trial\n\nExclusion Criteria:\n\nSubjects meeting one of the following criteria are not eligible for this study:\n\n1. Subject planned for intraoperative radiotherapy\n2. Subject planned for immediate reconstruction\n3. Neoadjuvant BC therapy\n4. Allergy to any NSAID or gabapentinoïd\n5. Known hypersensitivity reactions to the investigational treatments, or any excipients or auxiliary medicinal products or concomitant medications. Hypersensitive to peanut or soya (related to propofol contraindications)\n6. Current use of the antidiabetic agent thiazolidinedione (related to interaction with pregabalin), lithium salts, probenecid, pentoxifylline or intensive diuretic therapy.\n7. Current NSAID (\\> twice a week the year prior to diagnosis) or pregabalin use\n8. Previous malignant pathology within 5 years prior to inclusion or currently undergoing maintenance therapy. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer.\n9. Active or history of peptic ulcer disease or gastro-intestinal bleeding or perforation\n10. Pregnancy or lactating women\n11. Chronic inflammatory disease as rheumatoid arthritis, uncontrolled asthma, chronic heart failure, chronic obstructive pulmonary disease, cystic fibrosis, inflammatory myopathies (e.g., idiopathic polymyositis, dermatomyositis, inclusion body myositis), inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), McArdle's disease, multiple sclerosis, lupus, chronic inflammatory demyelinating polyneuropathy, psoriasis, autoimmune thyroiditis as Graves' disease or Hashimoto's thyroiditis (unless previous surgical ablation), myasthenia gravis, vasculitis.\n12. Complete or partial nasal polyposis syndrome, Quincke's oedema, bronchospasm, asthma\n13. Known chronic infectious disease as active hepatitis B (defined as positive serology for Ac anti-HBc and IgM anti HBc OR Ac anti HBc and Ag HBs), active hepatitis C (defined as positive serology for anti-VHC and positive PCR-VHC) or active tuberculosis (included under treatment)\n14. Uncontrolled HIV infection (defined as detectable viral loads by standard clinical assays) or controlled HIV infection (defined undetectable HIV viral loads by standard clinical assays) treated by one of following drugs: Nelfinavir, Atazanavir or Saquinavir (related to interaction with omeprazole).\n15. Infection currently treated with one of the following drugs: posaconazole, voriconazole, ketoconazole and rifampicin, unless discontinuation of treatment is planned at least 10 days prior to the start of study treatment AND with complete resolution according to expert opinion (related to interaction with omeprazole)\n16. Inadequate liver function (defined as total serum bilirubin ≥ 2 x upper limit of normal (ULN\\\u003C1.2 mg\u002Fdl) - unless documented Gilbert syndrome- AND Alanine Aminotransferase (ALT) ≥ 2 x ULN (ULN \\\u003C32 UI\u002Fl and ULN \\\u003C33 UI\u002Fl, respectively) AND Alkaline phosphatase (ALP) ≥ 2.5 x ULN (ULN=104 UI\u002Fl))\n17. Cirrhosis or severe hepatitis.\n18. Renal impairment (defined as GFR\\\u003C90ml\u002Fmin\u002F1.73m² or serum creatinine \\> 442 μmol\u002Fl or \\> 5 mg\u002FdL) or single kidney or previous renal surgery\n19. Subject with history of (severe) renal toxicity with an NSAID\n20. Subject with a recent history of operations associated with a high risk of bleeding\n21. Previous, ongoing or suspected cardiovascular disease defined as history of ischemic heart disease or heart failure or uncontrolled high blood pressure (Systolic ≥160mmHg and\u002For diastolic ≥100mmHg) or peripheral arterial disease or cerebrovascular disease\n22. Subject with a recent history of surgery associated with a high risk of bleeding\n23. Hemostasis disorder as haemophilia, Von Willebrand disease, constitutional thrombopathies or thrombocytopenia (defined as platelet count \\\u003C 100 000\u002Fmm³), current \u002Fplanned anticoagulant or anti-platelet therapy.\n24. Inadequate bone marrow function (defined as absolute neutrophil count \\\u003C1000\u002FμL and platelet count \\\u003C100'000\u002FμL)\n25. Systemic immunosuppressive treatment (defined as systemic corticotherapy or anti-rejection treatment or interferon therapy) within the 2-years prior diagnosis\n26. Psychiatric disease or antipsychotic\u002F antidepressant use\n27. Epilepsy or any current anti-epileptic drug use\n28. Obstructive sleep apnea\n29. ASA≥3","70 Years",{"count":274,"type":20},112,[23],"Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer.\n\nTo contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug.\n\nOur goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and\u002For eliminating residual disease using repurposing drugs",[278,26],"Early-stage Breast Cancer",[280,281,65,282,283,284,285,286,287],"Surgery","Inflammation","Neuronal features","Ketorolac","Pregabalin","Adiposity","Neurotransmitter","Nerves","2025-06-10",{"date":290,"type":34},"2025-06-13",{"date":292,"type":34},"2025-05-12",{"date":294,"type":20},"2027-10",{"name":296,"class":41},"Jules Bordet Institute",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":107},"100440865","phase-2-correlation-of-clinical-response-to-pathologic-response-in-patients-with-early-breast-cancer-100440865","NCT05020860","Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer","A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer","RESPONSE","Inclusion Criteria:\n\n* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.\n* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).\n\nTo be considered \"high risk,\" at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \\\u003C 6; 4) Ki-67 ≥ 30%.\n\n* Tumors must be at least 2 cm by clinical exam or ultrasound\n* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.\n* ECOG performance status of 0 or 1\n* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.\n* Adequate organ function, as determined by the following parameters:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1200\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome\n  * Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN\n  * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN\n  * Serum creatinine ≤ institutional ULN\n* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.\n* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of Stage IV disease\n* Inflammatory breast cancer\n* Participants who are pregnant or lactating\n* History of an excisional biopsy or lumpectomy performed prior to study entry\n* Prior treatment with anthracyclines for any malignancy.\n* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.\n* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:\n\n  * Angina pectoris requiring the use of anti-anginal medication\n  * Ventricular arrhythmias except for benign premature ventricular contractions\n  * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\n  * Conduction abnormality requiring a pacemaker\n  * Valvular disease with documented compromise in cardiac function\n  * Symptomatic pericarditis\n  * Documented cardiomyopathy\n  * History of documented congestive heart failure (CHF)\n  * Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.\n* Current HIV, hepatitis B, or hepatitis C infection\n* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.\n* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.\n* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.",{"count":306,"type":20},185,[23],"The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.",[56,310,249,311,312,313,93,314,252,315,251],"Breast Neoplasm","Breast Cancer Invasive","Breast Cancer Stage II","Breast Cancer Stage III","Hormone Receptor-positive Breast Cancer","Triple Negative Breast Neoplasms","2025-02-25",{"date":318,"type":34},"2025-02-27",{"date":320,"type":34},"2023-04-18",{"date":322,"type":20},"2029-11",{"name":324,"class":41},"Baylor Breast Care Center",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":333,"targetDuration":334,"studyType":335,"phases":4,"briefSummary":336,"conditions":337,"keywords":341,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":79},"100564033","early-changes-in-metabolic-health-in-breast-cancer-patients-initiating-endocrine-therapy-100564033","NCT06623903","Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy","Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study","EMETA","Inclusion Criteria:\n\n* Age ≥18 years\n* Invasive ER+ breast cancer\n* No diabetes treatment\n* Planned for initiation of any adjuvant endocrine therapy.\n\nExclusion Criteria:\n\n* Pregnancy or lactation,\n* Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.",{"count":274,"type":20},"3 Months","OBSERVATIONAL","This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.",[338,339,340],"Early Breast Cancer","Metabolic Health","Estrogen Receptor Positive Breast Cancer",[342,343,344],"Early breast cancer","Metabolic health","Endocrine therapy","2024-10-01",{"date":347,"type":34},"2024-10-02",{"date":349,"type":20},"2024-11-01",{"date":351,"type":20},"2025-07-31",{"name":353,"class":41},"Aarhus University Hospital"]