[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-epidermal-growth-factor-2-negative-carcinoma-of-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-epidermal-growth-factor-2-negative-carcinoma-of-breast":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,56,114,145,169,194],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100610025","phase-2-phii-randomized-capecitabine--elacestrant-vs-capecitabine-alone-in-er-breast-cancer-capela-100610025",false,"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.","ALL","18 Years",{"count":20,"type":21},297,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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)",[27,28,29,30,31,32,33,34,35],"Estrogen-receptor-positive Breast Cancer","Metastatic Breast Cancer","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",[37,28,38,39,40,32,41,42],"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","RECRUITING","2026-06-10",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2026-01-16",{"date":51,"type":21},"2030-10-01",{"name":53,"class":54},"Kristina A. Fanucci","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":96,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":64,"type":21},150,[66],"PHASE1","The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,31,95],"Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Progesterone-receptor-positive Breast Cancer",[97,98,99,100,101,102],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":105,"type":47},"2026-04-21",{"date":107,"type":47},"2024-09-19",{"date":109,"type":21},"2029-05",{"name":111,"class":112},"NiKang Therapeutics, Inc.","INDUSTRY",19,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100495736","phase-1-open-label-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-inx-315-in-patients-with-advanced-cancer-100495736","NCT05735080","Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer","INX-315-01","Inclusion Criteria:\n\n1. Advanced unresectable or metastatic HR+\u002FHER2- BC that has progressed following treatment with a CDK4\u002F6 inhibitor in the adjuvant or advanced\u002Fmetastatic setting.\n2. Advanced\u002F metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with known amplification of CCNE-1 that progressed after standard systemic therapy\n3. Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy\n4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated\n5. ECOG performance status score of 0 or 1.\n6. Adequate organ function as demonstrated by the following laboratory values:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n   3. Platelet count ≥ 100 × 10\\^9\u002FL\n   4. Estimated glomerular filtration rate (eGFR) of ≥60 mL\u002Fmin\n   5. Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases Part C: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits\n7. Negative pregnancy test\n\nExclusion Criteria:\n\n1. Have received previous therapy with a CDK2\u002F4\u002F6 inhibitor or CDK2 inhibitor.\n2. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.\n3. Have known intracranial hemorrhage and\u002For bleeding diatheses.\n4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.\n5. Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.\n6. Resting QTcF \\> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.\n7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication\n8. History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years.\n9. Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).\n10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.\n11. Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).\n12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.\n13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.\n14. Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug\n15. Prior irradiation to \\> 25% of the bone marrow\n16. Previous high-dose chemotherapy requiring prior stem cell transplant\n17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.\n18. Known or suspected hypersensitivity to active ingredient\u002Fexcipients in INX-315 or fulvestrant or abemaciclib.\n19. Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder\u002Factive inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n20. Has a serious and\u002For uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)",{"count":64,"type":21},[66,24],"Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced\u002Fmetastatic cancer, including hormone receptor positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \\[a CDK4\u002F6i\\] and fulvestrant \\[a SERD\\] in advanced\u002Fmetastatic breast cancer; dose escalation and expansion).",[29,126,127,31,73,93,69,128,129],"Breast Cancer Metastatic","Hormone Receptor Positive Tumor","Advanced Cancer","Metastatic Cancer",[131,132,133,134],"CDK2","CDK4\u002F6i","cyclin dependent kinase 2","CCNE1","2026-03-27",{"date":137,"type":47},"2026-04-01",{"date":139,"type":47},"2023-03-28",{"date":141,"type":21},"2027-09",{"name":143,"class":112},"Incyclix Bio",18,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":152,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100542843","phase-2-assessing-the-efficacy-and-safety-of-anti-her2-therapy-in-nigerian-women-with-her2-breast-cancer-before-and-after-surgery-100542843","NCT06348134","Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery","Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer","Inclusion Criteria:\n\nWritten informed consent must be obtained prior to any screening procedures\n\n1. Women ages of 18 to 70 years old\n2. Biopsy-accessible breast tumor of significant size for core needle biopsy \u002Fultrasound measurable (≥ 2cm)\n3. Measurable breast tumour using ultrasonography (≥ 2cm)\n4. Patients with histologically confirmed carcinoma of the female breast with positive HER2 status\n5. Clinical stages 2A -3C. (AJCC 2009)\n6. Chemotherapy-naïve patients (for this malignancy)\n7. Performance status: Eastern Cooperative Oncology Group performance status 0-3\n8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive hormone therapy with Zoladex (goserelin) for two years starting from the commencement of the study medications\n9. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:\n\n1\\. Granulocyte ≥ 1,500\u002FmL 2. Platelet count ≥ 100,000\u002FmL 3. Absolute neutrophil count ≥ l500\u002FmL 4. Hemoglobin 10g\u002FdL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) \\\u003C 2.5 x upper limit of normal for patients without liver metastases 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL\u002Fmin\u002F1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (see http:\u002F\u002Fmdrd.com\u002F for calculator) 8. Echocardiogram: Baseline left ventricular ejection fraction of ≥ 55%\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria:\n\n1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue the use of acceptable form of contraception for 7 months from the date of last drug administration (Herceptin).\n2. Patients with distant metastasis\n3. Serious, uncontrolled, concurrent infection(s).\n4. Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.\n5. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)\n6. Participation in any investigational drug study within 4 weeks preceding the start of study treatment\n7. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n8. Unwillingness to participate or inability to comply with the protocol for the duration of the study\n9. Patients with human epidermal growth factor receptor 2 (HER2-negative) disease\n10. History of documented heart failure or systolic dysfunction (LVEF \\\u003C 50%), High-risk uncontrolled arrhythmias ie, atrial tachycardia with a heart rate \\> 100\u002Fmin at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular (AV)-block (second degree AV-block Type 2 \\[Mobitz 2\\] or third degree AV-block),\n11. Angina pectoris requiring anti-anginal medication,\n12. Clinically significant valvular heart disease\n13. Poorly controlled hypertension (eg, systolic \\> 180 mm Hg or diastolic \\> 100 mm Hg)","FEMALE",{"count":154,"type":21},74,[24],"Doctors leading this study would like to learn about providing cancer treatment\u002Ftherapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.",[31,158,29],"HER2-positive Breast Cancer","2026-02-13",{"date":161,"type":47},"2026-02-17",{"date":163,"type":47},"2025-03-18",{"date":165,"type":21},"2036-07-01",{"name":167,"class":54},"University of Chicago",4,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":152,"minAge":18,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":55},"100552252","phase-2-study-of-shr-a1921-combined-adebrelimab-in-hr-positive-her2-negative-advanced-breast-cancer-100552252","NCT06470672","Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer","A Phase 2 Study of SHR-A1921 Combined Adebrelimab in Endocrine Therapy-failed HR-positive, HER2-negative Advanced Breast Cancer","Inclusion Criteria:\n\n* 18 years to 75 years old, female patients with breast cancer;\n* ECOG PS Score: 0\\~1;\n* Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;\n* PD-L1 positive;\n* Disease progression after at least prior 2 lines of endocrine therapy, and unable to benefit from further endocrine therapy determined by investigator, of which at least one line of CDK4\u002F6 inhibitor-based treatment; if recurrence or metastasis within 2 years after completion of adjuvant endocrine therapy, marked as first-line treatment;\n* Prior at least 1 line of systemic chemotherapy in recurrent or metastatic setting;\n* Based on RECIST v1.1, at least one measurable lesion;\n* Patients must have a life expectancy ≥ 3 months;\n* Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);\n* Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy;\n* Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.\n\nExclusion Criteria:\n\n* Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;\n* Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;\n* Prior anti-TROP-2 treatment;\n* Has received or been receiving PD-(L)1 inhibitors and\u002For ADC containing a topoisomerase inhibitor-like payload;\n* Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;\n* Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;\n* Use of other antitumor systemic treatment during the study;\n* Has active autoimmune disease or a history of autoimmune disease;\n* Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;\n* Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU\u002FmL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;\n* Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \\>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);\n* Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \\>10mg\u002Fd or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;\n* Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;\n* Hypersensitivity to study therapy or any of its excipients;\n* Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;\n* Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;\n* Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;\n* Other conditions that might influence the study and analysis of results in the opinion of the investigator.","75 Years",{"count":178,"type":21},32,[24],"Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.",[182,183,31],"Advanced Breast Cancer","Hormone-receptor-positive Breast Cancer","NOT_YET_RECRUITING","2024-12-17",{"date":187,"type":47},"2024-12-20",{"date":189,"type":21},"2024-12",{"date":191,"type":21},"2026-07",{"name":193,"class":54},"Fudan University",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":152,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100542113","palbociclib-in-metastatic-breast-cancer-gene-polymorphism-based-study-in-egyptian-patients-100542113","NCT06338644","Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.","Palbociclib","Inclusion Criteria:\n\n* 1\\. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive\u002FHER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.\n\n  4\\. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.\n\nExclusion Criteria:\n\n1. Prior exposure to fulvestrant or everolimus.\n2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.\n3. Patients refusing to sign the written informed consent.",{"count":202,"type":21},100,"OBSERVATIONAL","Cyclin-dependent kinase (CDK) 4\u002F6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies",[183,31,28],[207],"Metastatic breast Cancer, Palbociclib, Pharmacogenomic","2024-03-24",{"date":210,"type":47},"2024-03-29",{"date":212,"type":21},"2024-07-01",{"date":214,"type":21},"2026-09-01",{"name":216,"class":54},"Helwan University"]