[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"er-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:er-breast-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,74,100,127,158,194,225,252,276,302,329,351],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100587064","phase-2-circulating-tumor-dna-100587064",false,"NCT06923527","Circulating Tumor DNA","A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)","Inclusion Criteria for Screening:\n\n1. Adults aged 18 years and older.\n2. Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local laboratory as per ASCO\u002FCAP guidelines. In the context of this trial, ER status will be considered positive if \\>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone receptor positivity. Patients with PR positive but ER-negative are not eligible.\n3. Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 20 years ago and must have completed adjuvant endocrine therapy.\n4. Participants must be off endocrine therapy for at least four weeks prior to screening.\n\nExclusion Criteria for Screening:\n\n1. Known current metastatic disease.\n2. Known contraindication to receiving elacestrant as per FDA package insert.\n3. Current treatment with endocrine therapy.\n4. Prior treatment with elacestrant or other investigational SERDs.\n5. Current or past invasive cancer other than breast cancer, except:\n\n   1. Adequately treated basal or squamous cell carcinoma of the skin.\n   2. Cancer survivors of previously diagnosed invasive cancer who were treated with curative intent and have no evidence of disease recurrence for five years or more and are considered low risk for future recurrence by the treating physician.\n6. Patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.\n7. Current use of strong and moderate CYP3A4 inducers\u002Finhibitors or other prohibited concomitant medication unless an acceptable substitute is available, and the prohibited medication is discontinued at least five half-lives prior to initiation of elacestrant.\n8. Participants who are pregnant.\n\nInclusion Criteria for Treatment:\n\n1. ctDNA positivity by NEXT Personal assay.\n2. No evidence of metastatic disease on staging scans.\n\n   a. If imaging, after review with a radiologist, is low probability for metastatic disease, patients may proceed with enrollment. Patients with suspicious but inconclusive imaging results should undergo a diagnostic biopsy; if biopsy is negative patients are eligible for enrollment. Patients with positive imaging that is conclusive of metastatic disease, or biopsy proven metastatic disease, are not eligible.\n3. At the time of informed consent signature for treatment, participants may be either postmenopausal, premenopausal, or perimenopausal.\n\n   a. Postmenopausal status is defined by: i. Age ≥60. ii. Age \\\u003C60 and amenorrhea for 12 or more months (without an alternative cause) and FSH and estradiol level within postmenopausal range per local laboratory reference.\n\n   iii. Documentation of bilateral oophorectomy, at least one month before first dose of trial therapy.\n\n   b. Premenopausal and perimenopausal participants must be willing to concurrently receive an LHRH agonist, and the LHRH agonist must be initiated at least three to four weeks before the start of elacestrant and are planning to continue LHRH agonist treatment during treatment with elacestrant. This is based on the current FDA approval of elacestrant in the metastatic setting which is limited to postmenopausal participants.\n\n   c. Premenopausal or perimenopausal participants must be willing to use a highly effective method of contraception for the duration of trial treatment and for 120 days after the last dose of elacestrant OR if using barrier method of contraception must be willing to use a second form of contraception like occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository.\n\n   i. Highly effective methods of contraception are non-hormonal (cooper) intrauterine device (IUD), surgical sterilization (bilateral tubal occlusion\u002Fligation, partner who has had a vasectomy), and sexual abstinence.\n4. ECOG performance status of 0 or 1.\n5. Patient has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n   1. Absolute neutrophil count (ANC) \\>1.0 x 109\u002FL.\n   2. Platelets \\>100 x 109\u002FL.\n   3. Hemoglobin \\> 8.0 g\u002FdL.\n   4. Potassium, sodium, calcium, and magnesium CTCAE v5.0 grade \\\u003C1.\n   5. Cockcroft-Gault based creatinine clearance \\>50 mL\u002Fmin.\n   6. ALT and AST \\\u003C3 x ULN and total serum bilirubin \\\u003C1.5 x ULN.\n   7. Hypercholesterolemia and hypertriglyceridemia CTCAE v5.0 grade \\\u003C1.\n\nExclusion Criteria for Treatment:\n\n1. Any concurrent severe and uncontrolled medical condition that would, in the sponsor-investigator's opinion, cause unacceptable safety risks or compromise compliance with the protocol including but not limited to:\n2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (uncontrolled Crohn's disease or ulcerative colitis, uncontrolled chronic nausea, vomiting, diarrhea, malabsorption, or small bowel resection).\n3. Females who are pregnant or breastfeeding.\n4. Moderate to severe liver impairment (Child-Pugh Class B and C).\n5. Hypercholesterolemia or hypertriglyceridemia \\> CTCAE v5.0 grade 1.\n6. Participants who are currently or are planning lactation during elacestrant treatment. Lactation during and at least one week following the last dose of elacestrant is not allowed","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up.",[26],"ER+ Breast Cancer",[28,29,30],"stage IIB","stage III","ctDNA","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-29","ACTUAL",{"date":37,"type":35},"2025-09-30",{"date":39,"type":20},"2027-09",{"name":41,"class":42},"Yale University","OTHER",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100630102","phase-2-a-study-of-the-impact-of-endocrine-therapy-on-surgical-outcomes-in-people-with-lobular-breast-cancer-100630102","NCT07483307","A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer","Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study","Inclusion Criteria:\n\n* Written informed consent by participant or legally authorized representative\n* Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.\n* Tumors of the ER+\u002FHER2- subtype, defined as:\n\n  1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.\n  2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.\n\nExclusion Criteria:\n\n* Patients with prior ipsilateral breast cancer.\n* Patients with advanced regional disease (cN2\u002FcN3) or stage 4 disease.\n* Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.\n* Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).\n* Patients with gadolinium allergy, precluding the use of breast MRI.","FEMALE","50 Years",{"count":54,"type":20},176,[23],"The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).",[58,59,60,26,61],"Breast Cancer","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Lobular Breast Carcinoma",[58,59,60,26,63,64,65],"26-095","Memorial Sloan Kettering Cancer Center","Lobular Breast Cancer","2026-06-02",{"date":68,"type":35},"2026-06-04",{"date":70,"type":35},"2026-03-13",{"date":72,"type":20},"2030-03-13",{"name":64,"class":42},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100568426","breast-cancer-evolution-during-neoadjuvant-systemic-therapy-100568426","NCT06681064","Breast Cancer Evolution During Neoadjuvant Systemic Therapy","BELIEVE","Inclusion Criteria:\n\n1. Histologically confirmed non-metastatic invasive breast cancer.\n2. Be suitable for, but have not commenced, neoadjuvant chemotherapy, targeted therapy, or immunotherapy.\n3. If HER2-, suitable for treatment with upfront taxane chemotherapy. If HER2+, suitable for treatment with anti-HER2 targeted therapy.\n4. Be aged 18 years and over.\n5. Have given written informed consent to participate.\n\nExclusion Criteria:\n\n1. Metastatic breast cancer at diagnosis.\n2. Treatment with neoadjuvant endocrine therapy only.\n3. Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":82,"type":20},500,"OBSERVATIONAL","BELIEVE is a translational research study that aims to collect samples of breast cancer tissue and blood from individuals undergoing breast cancer treatment (such as chemotherapy, targeted therapy and immunotherapy) before surgery. In certain cases, MRI scans and stool samples will also be obtained before and during treatment. The samples collected from this study will be used for molecular and genetic research to understand why some cancers respond very well to anticancer treatments, and some do not, develop novel ways of accurately measuring response during treatment, as well as identify which patients are at a higher risk of the cancer coming back after surgery.",[58,86,26,87],"Triple Negative Breast Cancer","HER2+ Breast Cancer",[89],"Neoadjuvant Therapy","2026-04-13",{"date":92,"type":35},"2026-04-16",{"date":94,"type":35},"2024-05-29",{"date":96,"type":20},"2034-05",{"name":98,"class":42},"Royal Marsden NHS Foundation Trust",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100480319","phase-2-a-study-on-adding-precisely-targeted-radiation-therapy-stereotactic-body-radiation-therapy-to-the-usual-treatment-approach-drug-therapy-in-people-with-breast-cancer-100480319","NCT05534438","A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer","Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression","Inclusion Criteria:\n\n* Age 18 or older\n* Willing and able to provide informed consent\n* Metastatic breast cancer, biopsy proven\n\n  * ER+\u002FHER2-, defined as \\>5% ER+ staining\n  * HER2+ (regardless of ER status), including HER2-low and high expressors\n* History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)\n* Isolated site of disease progression on FDG PET scan\n* Consented to 12-245\n* ECOG performance status 0-1\n\nExclusion Criteria:\n\n* Pregnancy\n* Serious medical comorbidity precluding radiation, including connective tissue disorders\n* Intracranial disease (including previous intracranial involvement)\n* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.",{"count":108,"type":20},46,[23],"The purpose of this study is to see if using Stereotactic Body Radiation Therapy\u002FSBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.",[112,58,113,114,26,87],"Oligometastatic Breast Carcinoma","Metastatic Breast Cancer","Metastatic Breast Carcinoma",[116,117,26,87,113,118,119,64],"oligometastatic breast cancer","breast cancer","Stereotactic Body Radiation Therapy","22-259",{"date":92,"type":35},{"date":122,"type":35},"2022-09-06",{"date":124,"type":20},"2026-09-06",{"name":64,"class":42},8,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100390210","phase-1-pavement-palbociclib-and-avelumab-in-metastatic-ar-triple-negative-breast-cancer-100390210","NCT04360941","PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT","Inclusion Criteria Part A:\n\n1. Patients with recurrent inoperable locally advanced or metastatic breast cancer.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease. Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy.\n3. Measurable disease (RECIST 1.1)\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Women\u002Ffemale patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. 18 years of age or over.\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent.\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures\n\nInclusion Criteria Part B:\n\n1. Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival tissue from the primary tumour (which must have been ER\u002FPgR negative and collected within 5 years prior to metastatic relapse) may be used for AR testing if no archival metastatic tissue is available.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.\n3. Measurable disease (RECIST 1.1) amenable to fresh biopsy\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. Age 18 years of age or over\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up, and other procedures\n11. Available archival breast primary tumour tissue (or metastatic tissue if de novo metastatic disease)\n12. Patient willing to undergo a mandatory baseline fresh tumour tissue biopsy procedure (clinical or radiologically-guided)\n\nExclusion Criteria Parts A \\& B:\n\n1. Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal products during the previous four weeks.\n2. Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.\n3. Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received neoadjuvant and\u002For adjuvant pembrolizumab are eligible if treatment was completed at 6 months prior to metastatic relapse.)\n4. Previous treatment with palbociclib or any agents which inhibit CDK4\u002F6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12 months prior to metastatic relapse.)\n5. Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry\n6. Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression.\n7. Active infection requiring systemic therapy\n8. Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n9. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation\n10. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n11. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n12. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n13. Patients on warfarin or direct acting oral anticoagulants. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.\n14. Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection\n15. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)\n16. Inability or unwillingness to swallow pills, or receive IV injections.\n17. Persisting toxicity related to prior therapy \\>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).\n18. Pregnancy or lactation (women\u002Ffemales of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)\n19. Diagnosis of other malignancy within 3 years, except for previous breast cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, or low-grade (Gleason ≤6) prostate cancer\n20. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n21. Known prior or suspected hypersensitivity to investigational products or to any of the excipients\n22. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of avelumab.\n23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent\n24. Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at the beginning and during the course of the trial and discussed with the investigator.\n25. Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4).\n26. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose.\n27. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":136,"type":20},45,[138],"PHASE1","This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.\n\nThe study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.\n\nIt is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.",[86,141,142,113,26,143],"Locally Advanced Breast Cancer","Recurrent Breast Cancer","HER2-positive Breast Cancer",[145,146,147,148],"Palbociclib","Avelumab","Measurable Disease","Inoperable Disease","2026-03-31",{"date":151,"type":35},"2026-04-06",{"date":153,"type":35},"2020-08-11",{"date":155,"type":20},"2026-07-31",{"name":98,"class":42},9,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":181,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":193},"100546483","phase-1-a-study-of-parg-inhibitor-etx-19477-in-patients-with-advanced-solid-malignancies-100546483","NCT06395519","A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies","ERADIC8","Inclusion Criteria:\n\n* Males and females of age ≥ 18 years at the time of signing the informed consent document.\n* Histologically or cytologically confirmed advanced (incurable recurrent, unresectable, or metastatic) solid cancer, excluding primary central nervous system (CNS) tumors.\n* Any solid tumor malignancy, excluding primary CNS tumors, with progression on or after or intolerance to most recent systemic therapy. Preferential enrollment consideration will be made for patients with known BRCA2 mutations resulting in loss of function.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status 0-1.\n* Progression on or after or intolerance to most recent systemic therapy. Prior treatment in the recurrent\u002Fmetastatic setting; patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.\n* No investigational agent within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday. Chronic systemic corticosteroid therapy for physiologic replacement (≤10 mg\u002Fday of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted.\n* Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug.\n* Symptomatic untreated or progressing brain metastases. Stable, treated brain metastases are allowed if no evidence of radiologic or clinical progression or increasing corticosteroid use for at least 4 weeks.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ETX-19477 and no history of bowel obstruction within 6 months and\u002For peritoneal fluid drainage within 8 weeks prior to the first dose of study drug.\n* Known symptomatic and radiologically progressing or leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the Investigator, the patient must be free of neurological symptoms of LMD.\n* Resting ECG with QT interval calculated using the Fridericia's formula (QTcF) \\>470 msec on 2 or more timepoints within a 24-hour period, or history or family history of congenital long QT syndrome, or taking concomitant medications that are known to prolong the QT\u002FQTc interval, or history of additional risk factors for torsades de pointes (Tdp).\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, clinically significant uncontrolled arrhythmias, or any history of symptomatic congestive heart failure.\n* Known active or chronic infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B, hepatitis C, or AIDS-related illness. Controlled infections, including HIV and \"cured\" hepatitis C (no active fever, no evidence of systemic inflammatory response syndrome) that are stable with undetectable viral load on antiviral treatment are not exclusionary.\n* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).\n* Known other previous\u002Fcurrent malignancy requiring treatment within ≤2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma and not requiring ongoing chemotherapy.\n* Patients receiving proton pump inhibitors (PPIs), strong cytochrome P450 (CYP)3A inhibitors and inducers, or P-glycoprotein (P-gp) inhibitors. Patients should not receive PPIs within 7 days prior to first dose of study drug. Strong CYP3A inducers or inhibitors or strong P-gp inhibitors should not be given within 6 half-lives prior to first dose of study drug.\n* Patients currently treated with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants",{"count":166,"type":20},120,[138,23],"This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.",[170,58,171,172,173,174,26,175,176,177,178,179,180],"Advanced or Metastatic Solid Tumors","Ovarian Cancer","Prostate Cancer","Epithelial Ovarian Cancer","BRCA2 Mutation","Castrate Resistant Prostate Cancer","BRCA1 Mutation","BRCA Mutation","Endometrial Cancer","Colorectal Cancer","Gastric Cancer",[182],"PARG Inhibitor","2026-03-24",{"date":185,"type":35},"2026-03-27",{"date":187,"type":35},"2024-05-13",{"date":189,"type":20},"2026-12",{"name":191,"class":192},"858 Therapeutics, Inc.","INDUSTRY",14,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":204,"conditions":205,"keywords":210,"overallStatus":215,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":99},"100627064","evaluation-of-adherence-to-cell-cycle-inhibitors-used-as-adjuvant-therapy-in-patients-with-localized-breast-cancer-at-high-risk-of-recurrence-100627064","NCT07443774","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence.","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence","AdheRA","Inclusion Criteria\n\n* Male or female patients aged ≥18 years.\n* Operable invasive breast carcinoma of no special type, hormone receptor-positive \u002F HER2-negative (estrogen receptor expression \\>10% with or without progesterone receptor expression \\>10%; HER2-negative defined as score 0, 1+, or 2+ non-amplified).\n* M0 disease according to the TNM 2018 classification.\n* Having undergone curative surgery of the primary breast tumor.\n* Having received adjuvant radiotherapy, if indicated.\n* Indication for combined adjuvant endocrine therapy and iCDK4\u002F6 therapy validated during a multidisciplinary tumor board meeting.\n* Initiation of adjuvant endocrine therapy combined with a CDK4\u002F6 inhibitor between June 2023 and June 2028.\n* No objection to participation in the study.\n* Affiliation with the national health insurance system.\n\nNon-Inclusion Criteria\n\n* Medical, geographical, sociological, psychological, or legal conditions that could prevent the patient from completing the study or from providing informed non-opposition.\n* Locally advanced, non-operable disease or metastatic disease not amenable to curative-intent treatment",{"count":203,"type":20},81,"Hormone receptor-positive (HR+) breast cancers represent the most common histological subtype of breast cancer, accounting for approximately 75% of cases, regardless of HER2 (human epidermal growth factor receptor 2) status (1). Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors (AIs), is an effective pharmacological treatment for improving the prognosis of HR+ breast cancer, reducing the risk of recurrence by up to 50% (2-3-4-6). Despite its proven prognostic benefit, the full potential of endocrine therapy is not realized due to patient non-adherence (i.e., failure to comply with prescribed treatment). Adjuvant endocrine therapy is generally prescribed for a duration of 5 to 10 years. However, up to 40% of patients discontinue treatment prematurely, and 30% take the medication less frequently than prescribed. Poor adherence and low treatment persistence carry a substantial mortality burden: non-adherence is associated with a 49% increase in all-cause mortality. A retrospective analysis of a large database including more than 8,700 patients showed a 10-year survival rate of 80.7% among women who continued treatment, compared with 73.6% among those who discontinued adjuvant therapy prematurely (p \\\u003C 0.001). Among patients who continued treatment, the survival rate was 82% in those who were fully adherent, versus 78% in those who were only partially adherent (7-16).\n\nThe literature has documented a wide range of risk factors associated with non-adherence to or discontinuation of long-term adjuvant endocrine therapy. Treatment-related adverse effects, including hot flashes, joint stiffness, and sexual dysfunction, are common and may lead to treatment discontinuation. Fear of side effects may also prevent some patients from initiating or maintaining endocrine therapy. Others may not be fully convinced of the necessity of adjuvant endocrine therapy, particularly in the absence of overt signs of cancer. In addition, supportive care required to manage side effects is often inadequately reimbursed, making low income-combined with broader socioeconomic factors-a potential barrier to optimal adherence. Some patients may also experience difficulties remembering to take their medication regularly. The relative importance and contribution of these factors to non-adherence may evolve over time. Other factors may also play a role, including sociodemographic characteristics (low income, living alone, or unemployment).\n\nNevertheless, a residual risk of recurrence persists after five years of well-conducted standard endocrine therapy, extending up to two decades after diagnosis, particularly in patients with early-stage breast cancer stages II and III. In this higher-risk population, two phase III trials, monarchE and NATALEE, have recently evaluated the addition of a cell cycle inhibitor (CDK4\u002F6 inhibitor) to standard adjuvant endocrine therapy and reported positive results with a reduction in the risk of relapse.\n\nIn the NATALEE trial, quality of life was assessed in all patients in the ribociclib plus aromatase inhibitor group (n = 2,549) versus the aromatase inhibitor alone group (n = 2,552). Mean scores did not differ significantly from baseline for any of the analyzed domains. Similarly, no significant change from baseline was observed in either treatment group.\n\nHowever, it is important to note that 33.8% of patients discontinued ribociclib and 20% discontinued both endocrine therapy and ribociclib in the NATALEE trial, which is consistent with data from the literature.\n\nIn the monarchE trial, 16.6% of patients discontinued abemaciclib, and 6% discontinued both abemaciclib and endocrine therapy, while only 0.8% discontinued endocrine therapy in the control group. These findings are not consistent with previously published data.\n\nTo our knowledge, no real-world study has evaluated CDK4\u002F6 inhibitors in combination with endocrine therapy in the adjuvant treatment of HR+\u002FHER2-negative breast cancer.\n\nAdheRA is a prospective multicenter cohort study of patients with early-stage HR+\u002FHER2-negative breast cancer at high risk of recurrence, eligible for a combination of endocrine therapy and a CDK4\u002F6 inhibitor such as abemaciclib or ribociclib in the adjuvant setting, aiming to assess treatment adherence and the reasons for non-adherence.",[26,58,206,207,208,209],"Early Breast Cancer","Endocrine Therapy","Abemaciclib","Ribociclib",[211,212,213,214],"early breast cancer","celle cycle inhibitors","endocrine therapy","adjuvant setting","NOT_YET_RECRUITING","2026-02-26",{"date":218,"type":35},"2026-03-02",{"date":220,"type":20},"2026-04-01",{"date":222,"type":20},"2031-12",{"name":224,"class":42},"University Hospital, Grenoble",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":241,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":126},"100476939","phase-1-jab-2485-activity-in-adult-patients-with-advanced-solid-tumors-100476939","NCT05490472","JAB-2485 Activity in Adult Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Must be able to provide an archived tumor sample\n* Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor\n\n  * Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated\n* Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition\n* Must have at least 1 measurable lesion per RECIST v1.1\n* Must have adequate organ functions\n* Must be able to swallow and retain orally administered medication\n\nExclusion Criteria:\n\n* Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days\n* Active infection requiring systemic treatment within 7 days\n* Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV\n* Any severe and\u002For uncontrolled medical conditions\n* left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)\n* QT interval using Fridericia's formula (QTcF) interval \\>470 msec\n* Experiencing unresolved CTCAE 5.0 Grade \\>1 toxicities\n* Clinically significant eye disorders",{"count":233,"type":20},102,[138,23],"This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.",[237,26,238,239,240],"Solid Tumors","Triple Negative Breast Cancer, TNBC","ARID1A Gene Mutation","Small Cell Lung Cancer, SCLC",[242,239],"Aurora A inhibitor","2026-01-07",{"date":245,"type":35},"2026-01-09",{"date":247,"type":35},"2022-12-20",{"date":249,"type":20},"2027-08",{"name":251,"class":192},"Jacobio Pharmaceuticals Co., Ltd.",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":99},"100593110","phase-1-a-phase-ibii-study-to-evaluate-multiple-combination-therapies-of-fwd1802-in-patients-with-erher2--bc-100593110","NCT07002177","A Phase Ib\u002FII Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+\u002FHER2- BC","An Open-label, Multicenter, Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.\n* Histologically or cytologically confirmed ER-positive\u002FHER2-negative locally advanced or metastatic breast cancer\n* Subjects must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal\u002Fperimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment\n* Prior Therapy Requirements:Subjects must meet all of the following criteria:\n\n  1. Progression during\u002Fafter, intolerance to, ineligibility for, or refusal of standard therapy\n  2. Endocrine therapy history:\n\n     Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of prior endocrine therapy lines).\n  3. ≤2 prior lines of chemotherapy for ABC\n  4. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant\n  5. Everolimus combination arm: Prior CDK4\u002F6 inhibitor therapy requiredf) CDK4\u002F6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4\u002F6 inhibitor therapy;If only received adjuvant CDK4\u002F6 inhibitor therapy, recurrence must occur \\>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study.\n* Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed subjects with osteolytic bone lesion(s) confirmed by CT\u002FMRI.Phase II: At least one measurable lesion per RECIST v1.1.\n\nSubject must have sufficient organ and bone marrow functions at screening.\n\nExclusion Criteria:\n\n* Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases；\n* History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug\n* Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have more than 14 days of stabilization,\n* Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant\n* Inadequate washout period for prior anticancer therapies.\n* Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).\n* Subjects will be excluded if they meet any of the following:\n\n  1. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.\n  2. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic\n* Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) \\>150 mmHg OR Diastolic blood pressure (DBP) \\>95 mmHg.\n* Active cardiac disease or history of cardiac dysfunction","75 Years",{"count":261,"type":20},196,[138,23],"This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer",[113,265,266,267,26],"Breast Cancer Stage I","Breast Cancer Stage II","Locally Advanced Breast Cancer (LABC)","2026-01-05",{"date":243,"type":35},{"date":271,"type":35},"2025-06-01",{"date":273,"type":20},"2028-11-01",{"name":275,"class":192},"Forward Pharmaceuticals Co., Ltd.",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":283,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100375887","early-phase-1-fes-imaging-to-optimize-tamoxifen-for-metastatic-breast-cancer-100375887","NCT04174352","FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer","A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations","Inclusion Criteria:\n\n* Participants must have histologically confirmed breast cancer that is metastatic or unresectable with the following:\n\n  * Estrogen receptor expression by immunohistochemistry greater than or equal to 10%\n  * ESR1 mutation identified using a Clinical Laboratory Improvement Amendments (CLIA) certified assay via tumor biopsy tissue or circulating free DNA (cfDNA)\n  * human epidermal growth factor receptor 2 (HER2) negative\n* Participants must have measurable disease as defined by RECIST 1.1 or evaluable bone disease with at least one lesion measuring 10 mm or greater in size. (Participants with bone and non-bone disease are eligible. One disease site must meet either the measurable or evaluable criteria outlined.) Participants with liver-only disease are not eligible due to the inherent hepatic uptake related to the radiopharmaceutical's hepatobiliary route of elimination.\n* Participants must have received at least 1 prior line of endocrine therapy in the metastatic setting or have had progression within 12 months of adjuvant endocrine therapy. Prior Tamoxifen is allowed in any setting. Prior CDK4\u002F6 in the metastatic setting per NCCN guidelines is allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (See Appendix A)\n* Life expectancy of greater than 12 weeks.\n* Ability to take oral medications.\n* Informed consent: participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.\n* Participants with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at least 1 month.\n* Participants must have adequate normal organ and bone marrow function as defined below:\n\n  * Absolute neutrophil count \\>\u002F= 1,000\u002FmcL\n  * Hemoglobin \\>\u002F= 9.0 g\u002FdL\n  * Platelets \\>\u002F= 100,000\u002FmcL\n  * Total bilirubin \\\u003C\u002F= 1.5 x upper limit of normal (ULN)\n  * AST (SGOT)\u002F ALT (SGPT) \\\u003C\u002F= 2.5 x ULN; \\\u003C\u002F= 5 x ULN in the setting of metastatic liver disease\n  * Creatinine \\\u003C\u002F= 1.5 x ULN or creatinine clearance \\>\u002F= 50 mL\u002Fmin\n\nExclusion Criteria:\n\n* Prior chemotherapy, radiotherapy, targeted, immunotherapy or investigational therapy within 2 weeks or major surgery within 4 weeks of study enrollment or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events due to agents administered more than 2 weeks earlier (alopecia and fatigue excluded).\n* Participants must not be receiving an ER blocking endocrine therapy (includes fulvestrant, tamoxifen, toremifene, raloxifene) and must be off the agents for a minimum of 60 days prior to planned FES PET\u002FCT to allow for adequate uptake of FES.\n* History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of tamoxifen or \\[18F\\]-fluoroestradiol.\n* Peripheral neuropathy of severity greater than grade 1.\n* Current optic nerve disorders, retinopathy, lattice degeneration, macular degeneration, retinal vascular disorder, or retinal tears of severity greater than grade 1.\n* History of cerebellar disorders, ataxia, and uncontrolled seizures unless related to transient medical condition and in investigator's opinion is not an active medical issue.\n* History of venous thrombosis\u002Fthromboembolic event, including pulmonary embolism and stroke.\n* Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 470msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, chronic hypokalemia, family history of long QT interval syndrome).\n* Are taking medications that are known to prolong the QT interval, unless they can be transferred to other medications ≥ 5 half-lives prior to dosing or unless the medications can be properly monitored during the study. If equivalent medication is not available, QTcF should be closely monitored.\n* Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant women. Tamoxifen use during pregnancy may have a potential long-term risk to the fetus of a Diethylstilbestrol syndrome (DES)-like syndrome. Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative urine\u002Fserum pregnancy test within 14 days of tamoxifen treatment). In addition, a medically acceptable method of birth control must be used such as an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 3 months after last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.\n* Ongoing treatment with other investigational agents. Participants cannot be receiving concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment.\n* History of uterine malignancy unless participant has had hysterectomy with no evidence recurrent disease for ≥ 3 years from definitive therapy.\n* Concurrent malignancy except for the following:\n\n  * Basal cell or squamous cell skin cancer\n  * In situ cervical cancer\n* The following medications are contraindicated or must be used with caution.\n\n  * Contraindicated:\n\n    * CYP2D6, CYP3A4, and CYP2C9 strong inhibitors\n    * CYP2D6, CYP3A4, and CYP2C9 strong inducers\n  * Use with caution:\n\n    * CYP2C9 sensitive substrates\n    * CYP2D6 moderate inhibitors or inducers\n    * CYP3A4 moderate inhibitors or inducers\n\nNote: Transdermal products designed for systemic delivery must be assessed for interaction potential. Topical products not designed to provide systemic delivery (including inhaled products, ophthalmologic products and transvaginal preparations) do not need to be considered.\n\nContraindicated medications are not allowed. Participants taking these concurrent medications are ineligible unless they can discontinue or switch to alternative medications prior to initiation of study drug (at least 5 half-lives).\n\nUse with caution agents are permitted if a) discontinuation is not feasible or b) no acceptable alternatives are available as determined by the treating physician; however, caution should be used. Consider monitoring by symptoms, labs or drug levels and dose adjustments of the medication.\n\n* Uncontrolled intercurrent clinically significant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","19 Years",{"count":285,"type":20},12,[287],"EARLY_PHASE1","Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always \"turned on\" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. \\[18F\\]-fluoroestradiol Positron Emission Tomography\u002FComputed tomography (FES-PET\u002FCT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET\u002FCT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.",[290,291],"ERα+ Breast Cancer","ESR1 Gene Mutation","2025-12-15",{"date":294,"type":35},"2025-12-22",{"date":296,"type":35},"2020-10-20",{"date":298,"type":20},"2027-12",{"name":300,"class":42},"University of Wisconsin, Madison",2,{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":51,"minAge":310,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":301},"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":312,"type":20},114,[314],"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.",[58,317,318,59,26,319],"Cancer","Cancer of the Breast","Estrogen-receptor-positive Breast Cancer","2025-11-12",{"date":322,"type":35},"2025-11-13",{"date":324,"type":35},"2025-10-27",{"date":326,"type":20},"2033-05",{"name":328,"class":42},"Youssef Zeidan",{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100438129","phase-2-a-trial-of-early-detection-of-molecular-relapse-with-circulating-tumour-dna-tracking-and-treatment-with-palbociclib-plus-fulvestrant-versus-standard-endocrine-therapy-in-patients-with-er-positive-her2-negative-breast-cancer-100438129","NCT04985266","A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer","A Randomised Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer","TRAK-ER","Inclusion Criteria for ctDNA Surveillance:\n\n1. Written informed consent to participate in the trial and to donation of tissue and blood samples\n2. Male or female patients aged 18 years or older\n3. ECOG performance status 0, 1 or 2 (see https:\u002F\u002Fecog-acrin.org\u002Fresources\u002Fecog-performance-status)\n4. Histologically proven primary ER+ (Allred score 6\u002F8 or greater, or stain in ≥10% of cancer cells) and HER2- (immunohistochemistry 0\u002F1+ and\u002For negative by in situ hybridization) breast cancer as determined by local laboratory\n5. Patients with high risk early stage breast cancer according to at least one of the following criteria:\n\n   Primary surgery (no other treatment prior to surgery) A. Four or more involved axillary lymph nodes or positive supraclavicular lymph node at diagnosis, or\n\n   B. Tumour size \\> 5 cm, regardless of lymph node status, or\n\n   C. 1-3 involved axillary lymph nodes and at least one of the following; i) Tumour size \\> 3 cm, ii) histological grade 3 iii) high genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Prosigna score \\>=60, EPclin risk score \\>=4.0, or Mammaprint high risk category, or\n\n   Neoadjuvant chemotherapy (chemotherapy prior to surgery)\n\n   D. At least one lymph node positive (micrometastasis or macrometastasis) after chemotherapy\n\n   E. Lymph node negative and tumour size \\> 3 cm after chemotherapy\n\n   Neoadjuvant endocrine therapy (endocrine based therapy prior to surgery) Use the primary surgery criteria - staging tumour size and lymph node status may be either the pathological staging after endocrine therapy or on the initial clinical staging prior to neoadjuvant therapy\n6. Available tissue from one archival tumour tissue sample (either from diagnostic biopsy, primary surgery or where available residual disease post-neoadjuvant chemotherapy)\n7. No evidence of macroscopic distant metastatic disease or incurable locally advanced disease on staging scans conducted at any time since initial diagnosis.\n8. Patients receiving standard endocrine therapy with aromatase inhibitors (letrozole, anastrazole, exemestane), tamoxifen, or combination of such for a minimum of 6 months\\* and maximum of 7 years duration with an additional three years of endocrine therapy planned. Pre- or peri-menopausal patients may also receive GnRH analogues.\n\n   \\* patients may enrol during the first 6 months of standard endocrine therapy, and wait until at least 6 months of endocrine therapy has been received prior to starting ctDNA surveillance\n9. Patients must have had surgery achieving clear margins (as per local guidelines)\n10. Female and male patients of reproductive potential must be willing to use an adequate method of contraception for the first three years of the trial, if randomised to standard endocrine therapy for the duration of trial treatment through to at least 4 weeks after the last dose of trial treatment, and if randomised to fulvestrant and palbociclib to 2 years after the last dose of fulvestrant (see section 4.6). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.\n11. Patients willing to have frequent blood tests.\n\nInclusion Criteria for Interventional phase:\n\n1. Signed informed consent for treatment\n2. ECOG performance status 0, 1 or 2\n3. Women of childbearing potential should have a negative serum pregnancy test prior to randomisation. If randomisation occurs more than 72 hours prior to receiving the first dose of treatment the test must be repeated before treatment.\n4. Female and male patients of childbearing potential must be willing to use an adequate method of contraception (section 4.6), starting with the first dose of treatment through 4 weeks after the last dose of treatment if randomised to standard endocrine therapy and 2 years after the last dose of fulvestrant if randomised to fulvestrant and palbociclib. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Female patients will be deemed not of childbearing potential if they are postmenopausal or have had irreversible sterilisation\n5. Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 109\u002FL\n   2. Platelets ≥ 100 × 109\u002FL\n   3. Haemoglobin ≥ 100 g\u002FL\n   4. INR ≤1.5\n   5. Creatinine \\\u003C1.5 x ULN and creatinine clearance ≥30ml\u002Fmin\n   6. Total bilirubin \\\u003C ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.\n   7. Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n   8. Aspartate aminotransferase (AST) \\\u003C 2.5 × ULN\n6. Patients must be post-menopausal OR\n\nPre- or peri-menopausal patients or men may be enrolled if they have ovarian\u002Fgonadal suppression with licensed GnRH analogues. Patients must have commenced licensed GnRH analogues at least 2 weeks prior to Cycle 1 Day 1 and continue throughout the study if randomised to fulvestrant and palbociclib.\n\nPost-menopausal female patients, as defined by at least one of the following:\n\n* Age ≥60 years;\n* Age \\\u003C60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and FSH levels within the institutional laboratory's reference range for post-menopausal females;\n* Documented bilateral oophorectomy;\n\nExclusion Criteria for ctDNA Surveillance:\n\n1. Any concurrent or planned treatment for the current diagnosis of breast cancer other than adjuvant endocrine therapy or a bisphosphonate.\n2. Patients with prior exposure to a CDK 4\u002F6 inhibitor as part of standard of care may enrol only after at least 12 months from completing CDK4\u002F6 therapy.\n3. Prior exposure to therapeutic dose of fulvestrant is not permitted. One subtherapeutic dose of fulvestrant is permitted.\n4. Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for non-melanoma carcinoma of the skin or cervical carcinoma in situ\n5. Patients previously entered into a therapeutic trial where experimental therapy is continued post-surgery. Patients who have entered a clinical trial of a CDK4\u002F6 inhibitor in the adjuvant setting are not eligible. Patients who received a CDK4\u002F6 inhibitor only before an operation, with no post-operative adjuvant use, are eligible.\n6. Treatment with an unlicensed or investigational product within 4 weeks prior registration to trial\n7. Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic therapy, not including side-effects of endocrine therapy\n8. Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)\n9. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.\n10. Clinically significant uncontrolled heart disease including any of the following:\n\n    1. History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry\n    2. Symptomatic congestive heart failure\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.\n    4. Cardiac arrhythmia.\n11. History of pneumonitis, interstitial lung disease or pulmonary fibrosis\n12. Known history of Human Immunodeficiency Virus (HIV) (testing not required as part of study screening)\n13. Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)\n14. Females who are known to be pregnant or breastfeeding\n15. History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH), low dose aspirin or clopidogrel are permitted.\n16. Child-Pugh class C hepatic impairment or creatinine clearance \\\u003C 30ml\u002Fmin.\n17. Patient with bilateral tumours, or unilateral multifocal cancers with multiple separate primary cancers.(Multifocal cancer that reflects a single primary cancer, in the opinion of the investigator, are eligible)\n\nExclusion Criteria for Interventional phase:\n\n1. Evidence of recurrent disease (metastatic or local, see section 6.6 for management of patients with potentially curable local recurrences) on staging scans conducted since positive ctDNA result\n2. Known hypersensitivity to the excipients of palbociclib plus fulvestrant\n3. Any anti-cancer treatment since enrolling in the TRAK-ER study other than hormonal therapy or a bisphosphonate. Prior exposure to fulvestrant is not permitted.\n4. Diagnosis of an alternative cancer since enrolment in the trial other than non-melanoma cancer of the skin or cervical carcinoma in situ\n5. Patient has had major surgery within 4 weeks prior to starting trial treatment or has not recovered from major side effects of such procedure\n6. Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with unfractionated heparin, low molecular weight heparin (LMWH), or a direct-acting oral anticoagulant (DOAC such as rivaroxaban or fondaparinux) is allowed\n7. Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic therapy, not including side-effects of endocrine therapy\n8. Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)\n9. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.\n10. Clinically significant uncontrolled heart disease including any of the following:\n\n    1. History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry\n    2. Symptomatic congestive heart failure\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.\n    4. Cardiac arrhythmia.\n11. Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:\n\n    * Medications that are strong inducers or inhibitors of CYP3A4 (section 8.5.2)\n    * Herbal preparations\u002Fmedications, dietary supplements, fruits (e.g grapefruit, pomelos, starfruit, Seville oranges) and their juice\n12. History of pneumonitis, interstitial lung disease or pulmonary fibrosis\n13. Known history of HIV (testing not required as part of study screening)\n14. Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)\n15. Patient has a history of non-compliance to medical regimen\n16. History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH), low dose aspirin or clopidogrel are permitted.\n17. Females who are known to be pregnant or breastfeeding.",{"count":338,"type":20},1100,[23],"Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse.\n\nThe TRAK-ER trial will have two phases, a ctDNA surveillance phase and a randomised therapy trial in patients with positive ctDNA.\n\nThe TRAK-ER trial will establish a ctDNA screening programme for patients with ER positive breast cancer receiving adjuvant endocrine therapy with at least a further three years of standard adjuvant endocrine therapy planned. Patients recruited into the TRAK-ER study will have high-risk clinical features to identify patients at higher risk of future relapse.\n\nctDNA assays will be used to identify which people are at very high risk of relapse (i.e. those with a positive ctDNA result), and randomise this high risk population between standard endocrine therapy versus palbociclib plus fulvestrant for up to two years.",[26,59],"2024-12-03",{"date":344,"type":35},"2024-12-05",{"date":346,"type":35},"2022-03-30",{"date":348,"type":20},"2030-09-01",{"name":98,"class":42},49,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":215,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":4},"100547394","phase-3-improvement-of-quality-of-life-through-supportive-treatments-for-hormone-therapy---related-symptoms-in-patients-with-early-breast-cancer-100547394","NCT06407401","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer; A Pragmatic Randomized Controlled Trial","Inclusion criteria:\n\n* Female (both pre- and postmenopausal) or male patients\n* Age ≥18 years\n* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III\n* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction\n* Present endocrine therapy related MSK pain (arthralgia and\u002For bone pain and\u002For myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:\n\n  * Grade 2: moderate pain; limiting instrumental activities daily living (ADL)\n  * Grade 3: severe pain; limiting activities self-care ADL\n* Previous chemotherapy is allowed if completed at least 3 months before enrolment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Adequate organ function\n* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)\n* Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing \u002F reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.\n\nExclusion criteria:\n\n* Current history of moderate\u002Fsevere depression and\u002For anxiety, both defined as grade≥2 CTCAE V5.0\n* History of suicide-related events\n* Current use of diuretics, antidepressants and\u002For phytoestrogens\n* Current use of prescribed or natural medicines with known interactions with furosemide and\u002For duloxetine\n* Contraindications to duloxetine:\n\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Uncontrolled hypertension\n  * Hepatic impairment Child Pugh Class B or C\n* Contraindications to furosemide:\n\n  * Symptomatic hypotension, hypovolemia, or dehydration\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Severe hypokalaemia and\u002For severe hyponatremia\n  * Addison's disease\n  * Porphyria\n* Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Participation in another interventional study with drugs.",{"count":359,"type":20},399,[361],"PHASE3","This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+\u002FHER2- early breast cancer with joint, muscle and\u002For bone pain caused by the endocrine therapy.\n\nThe purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and\u002For bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).",[26,59,265,266,364,365,366],"Breast Cancer Stage III","Drug-Related Side Effects and Adverse Reactions","Musculoskeletal Pain",[368],"Quality of Life","2024-11-04",{"date":371,"type":35},"2024-11-05",{"date":373,"type":20},"2024-12",{"date":375,"type":20},"2028-11-30",{"name":377,"class":378},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK"]