{"id":"palbociclib-letrozole-or-fulvestrant","safety":{"commonSideEffects":[{"rate":"40–60","effect":"Neutropenia"},{"rate":"30–50","effect":"Leukopenia"},{"rate":"20–30","effect":"Anemia"},{"rate":"30–40","effect":"Fatigue"},{"rate":"20–30","effect":"Nausea"},{"rate":"15–25","effect":"Diarrhea"},{"rate":"10–20","effect":"Hot flashes"},{"rate":"10–20","effect":"Arthralgia"}]},"_chembl":{"chemblId":"CHEMBL1444","moleculeType":"Small molecule","molecularWeight":"285.31"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Palbociclib is a CDK4/6 inhibitor that prevents phosphorylation of the retinoblastoma protein, halting G1/S cell cycle transition in hormone receptor-positive breast cancer cells. Letrozole blocks estrogen synthesis via aromatase inhibition, while fulvestrant degrades the estrogen receptor itself. The combination leverages dual mechanisms: cell cycle arrest plus hormonal suppression.","oneSentence":"Palbociclib inhibits cyclin-dependent kinases 4 and 6 to block cell cycle progression, combined with either letrozole (aromatase inhibitor) or fulvestrant (estrogen receptor antagonist) to suppress hormone-driven breast cancer growth.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:51.525Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, HER2-negative metastatic or advanced breast cancer (first-line or subsequent lines, depending on trial arm)"}]},"trialDetails":[{"nctId":"NCT06635447","phase":"PHASE3","title":"Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2024-09-26","conditions":"Breast Cancer","enrollment":258},{"nctId":"NCT05564377","phase":"PHASE2","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-04-07","conditions":"Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8","enrollment":2900},{"nctId":"NCT07354022","phase":"PHASE3","title":"A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-03-04","conditions":"Locally Advanced or Metastatic Breast Cancer","enrollment":912},{"nctId":"NCT06726148","phase":"PHASE1, PHASE2","title":"Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-04-03","conditions":"Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors","enrollment":280},{"nctId":"NCT05307705","phase":"PHASE1","title":"A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2022-05-11","conditions":"Breast Cancer","enrollment":193},{"nctId":"NCT07498478","phase":"PHASE2","title":"Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment","status":"RECRUITING","sponsor":"TransThera Sciences (Nanjing), Inc.","startDate":"2026-03-17","conditions":"Breast Cancer","enrollment":94},{"nctId":"NCT05601440","phase":"PHASE2","title":"Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Canadian Cancer Trials Group","startDate":"2023-06-13","conditions":"Breast Cancer","enrollment":484},{"nctId":"NCT06998407","phase":"PHASE1, PHASE2","title":"ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors","status":"RECRUITING","sponsor":"Avenzo Therapeutics, Inc.","startDate":"2025-08-20","conditions":"HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer","enrollment":380},{"nctId":"NCT07492641","phase":"PHASE3","title":"BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease","status":"NOT_YET_RECRUITING","sponsor":"BeOne Medicines","startDate":"2026-05-11","conditions":"HR+/HER2- Breast Cancer","enrollment":1056},{"nctId":"NCT06625775","phase":"PHASE1","title":"Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","status":"RECRUITING","sponsor":"TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)","startDate":"2024-10-29","conditions":"Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer","enrollment":392},{"nctId":"NCT06428396","phase":"PHASE2","title":"Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-11-27","conditions":"Metastatic Breast Cancer","enrollment":120},{"nctId":"NCT05467891","phase":"PHASE2","title":"Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer","status":"RECRUITING","sponsor":"Oana Danciu","startDate":"2022-09-13","conditions":"Locoregional Recurrence, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer","enrollment":200},{"nctId":"NCT07109726","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations","status":"RECRUITING","sponsor":"Terremoto Biosciences Inc.","startDate":"2025-09-23","conditions":"Breast Cancer, Endometrial Cancer, Ovarian Cancer","enrollment":205},{"nctId":"NCT07114601","phase":"PHASE1","title":"A Study of LY4257496 in Participants With Cancer (OMNIRAY)","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2025-08-06","conditions":"Breast Neoplasms, Colorectal Neoplasms, Prostate Neoplasm","enrollment":421},{"nctId":"NCT07347600","phase":"","title":"A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2026-01-21","conditions":"Locally Advanced Breast Cancer, Metastatic Breast Cancer","enrollment":500},{"nctId":"NCT07174336","phase":"PHASE3","title":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2025-12-22","conditions":"Breast Neoplasms, Neoplasm Metastasis","enrollment":920},{"nctId":"NCT05573126","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer","status":"RECRUITING","sponsor":"Ellipses Pharma","startDate":"2023-01-11","conditions":"Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer","enrollment":95},{"nctId":"NCT04576455","phase":"PHASE2","title":"A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-11-27","conditions":"Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer","enrollment":303},{"nctId":"NCT03573648","phase":"PHASE2","title":"Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2018-11-13","conditions":"Breast Cancer","enrollment":33},{"nctId":"NCT00099437","phase":"PHASE3","title":"Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2005-02-13","conditions":"Breast Cancer","enrollment":736},{"nctId":"NCT07226349","phase":"PHASE1","title":"A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors","status":"RECRUITING","sponsor":"BeOne Medicines","startDate":"2025-12-11","conditions":"Advanced Solid Tumor","enrollment":105},{"nctId":"NCT06377852","phase":"PHASE3","title":"The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study","status":"RECRUITING","sponsor":"American Society of Clinical Oncology","startDate":"2024-10-29","conditions":"Metastatic Breast Cancer","enrollment":500},{"nctId":"NCT05654623","phase":"PHASE3","title":"A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2023-03-03","conditions":"Advanced Breast Cancer","enrollment":624},{"nctId":"NCT06120283","phase":"PHASE1","title":"BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","status":"RECRUITING","sponsor":"BeiGene","startDate":"2023-12-01","conditions":"Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer","enrollment":300},{"nctId":"NCT07480681","phase":"PHASE1","title":"Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2026-03","conditions":"Advanced/Metastatic Solid Tumors","enrollment":138},{"nctId":"NCT07038369","phase":"PHASE1","title":"A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations","status":"ACTIVE_NOT_RECRUITING","sponsor":"Atavistik Bio, Inc","startDate":"2025-07-29","conditions":"Advanced Solid Tumors, Breast Cancer, Breast Carcinoma","enrollment":134},{"nctId":"NCT06993844","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Ensem Therapeutics","startDate":"2025-06-10","conditions":"Advanced Solid Tumors, Advanced Breast Cancer","enrollment":233},{"nctId":"NCT04191499","phase":"PHASE2, PHASE3","title":"A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-01-29","conditions":"Breast Cancer","enrollment":325},{"nctId":"NCT06997029","phase":"PHASE1","title":"A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-08-01","conditions":"Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer","enrollment":234},{"nctId":"NCT03643510","phase":"PHASE2","title":"Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2018-08-21","conditions":"Adenocarcinoma of Endometrium","enrollment":28},{"nctId":"NCT05230810","phase":"PHASE1, PHASE2","title":"Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Criterium, Inc.","startDate":"2022-08-25","conditions":"HER2-positive Metastatic Breast Cancer","enrollment":40},{"nctId":"NCT03424005","phase":"PHASE1, PHASE2","title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2018-03-30","conditions":"Metastatic Breast Cancer","enrollment":792},{"nctId":"NCT07368998","phase":"PHASE2","title":"To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2026-02-18","conditions":"Breast Cancer","enrollment":80},{"nctId":"NCT06843967","phase":"PHASE1, PHASE2","title":"A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2025-02-19","conditions":"Well Differentiated Liposarcoma, Dedifferentiated Liposarcoma, Liposarcoma","enrollment":54},{"nctId":"NCT06016738","phase":"PHASE3","title":"OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer","status":"RECRUITING","sponsor":"Olema Pharmaceuticals, Inc.","startDate":"2023-11-16","conditions":"Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer","enrollment":510},{"nctId":"NCT06736704","phase":"PHASE1, PHASE2","title":"SNV4818 in Participants With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Pikavation Therapeutics, Inc.","startDate":"2025-02-20","conditions":"Advanced Solid Tumors","enrollment":320},{"nctId":"NCT07287917","phase":"PHASE1, PHASE2","title":"Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors","status":"RECRUITING","sponsor":"Aminex Therapeutics, Inc.","startDate":"2026-01-26","conditions":"Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer","enrollment":92},{"nctId":"NCT06380751","phase":"PHASE3","title":"Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2024-08-01","conditions":"Advanced Breast Cancer","enrollment":500},{"nctId":"NCT04862663","phase":"PHASE3","title":"Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2021-05-10","conditions":"Locally Advanced (Inoperable) or Metastatic Breast Cancer","enrollment":895},{"nctId":"NCT05524584","phase":"PHASE2","title":"Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer","status":"RECRUITING","sponsor":"University of California, Irvine","startDate":"2022-08-31","conditions":"Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer","enrollment":20},{"nctId":"NCT03006172","phase":"PHASE1","title":"To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genentech, Inc.","startDate":"2016-12-13","conditions":"Breast Cancer, Solid Tumor","enrollment":200},{"nctId":"NCT06506955","phase":"PHASE2, PHASE3","title":"Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.","status":"ENROLLING_BY_INVITATION","sponsor":"Taiho Oncology, Inc.","startDate":"2024-10-01","conditions":"Advanced/Metastatic Cancer","enrollment":15},{"nctId":"NCT04572295","phase":"PHASE1","title":"A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eisai Co., Ltd.","startDate":"2020-10-09","conditions":"Breast Neoplasms","enrollment":51},{"nctId":"NCT04931342","phase":"PHASE2","title":"A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2021-10-07","conditions":"Ovarian Cancer","enrollment":176},{"nctId":"NCT06065748","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2023-12-11","conditions":"Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer","enrollment":1050},{"nctId":"NCT07405801","phase":"PHASE2","title":"A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2026-03-31","conditions":"Breast Cancer","enrollment":80},{"nctId":"NCT06979596","phase":"PHASE2","title":"A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-08-11","conditions":"Malignant Neoplasm","enrollment":250},{"nctId":"NCT03531645","phase":"PHASE2","title":"Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-08-13","conditions":"Malignant Neoplasms of Female Genital Organs","enrollment":18},{"nctId":"NCT06257264","phase":"PHASE1","title":"A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors","status":"RECRUITING","sponsor":"BeiGene","startDate":"2024-03-11","conditions":"Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer","enrollment":258},{"nctId":"NCT05894239","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2023-09-08","conditions":"Metastatic Breast Cancer","enrollment":230},{"nctId":"NCT05546268","phase":"PHASE1, PHASE2","title":"Study of Oral MRT-2359 in Selected Cancer Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Monte Rosa Therapeutics, Inc","startDate":"2022-10-12","conditions":"NSCLC, SCLC, High Grade Neuroendocrine Cancer","enrollment":174},{"nctId":"NCT05554354","phase":"PHASE2","title":"Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2024-09-13","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma","enrollment":1},{"nctId":"NCT05154487","phase":"PHASE2","title":"A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"GOG Foundation","startDate":"2024-09-11","conditions":"Endometroid Endometrial Cancer","enrollment":51},{"nctId":"NCT06982521","phase":"PHASE3","title":"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer","status":"RECRUITING","sponsor":"Relay Therapeutics, Inc.","startDate":"2025-08-26","conditions":"PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor","enrollment":540},{"nctId":"NCT01560416","phase":"PHASE2","title":"Fulvestrant With or Without Ganetespib in HR+ Breast Cancer","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2012-06","conditions":"Breast Cancer","enrollment":50},{"nctId":"NCT05768139","phase":"PHASE1, PHASE2","title":"First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2023-04-17","conditions":"Breast Cancer, Solid Tumors, Adult","enrollment":720},{"nctId":"NCT06486883","phase":"PHASE2","title":"Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype","status":"RECRUITING","sponsor":"MedSIR","startDate":"2025-06-30","conditions":"Advanced Breast Cancer, Advanced Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma","enrollment":200},{"nctId":"NCT07389733","phase":"PHASE1, PHASE2","title":"A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-02","conditions":"Advanced Unresectable or Metastatic Breast Cancer of Adults","enrollment":180},{"nctId":"NCT06760637","phase":"PHASE3","title":"Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease","status":"RECRUITING","sponsor":"Pfizer","startDate":"2025-01-06","conditions":"Breast Cancer","enrollment":1020},{"nctId":"NCT04498481","phase":"","title":"TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-03-01","conditions":"Breast Cancer","enrollment":1},{"nctId":"NCT06179303","phase":"PHASE2","title":"Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer","status":"RECRUITING","sponsor":"University of Washington","startDate":"2024-07-22","conditions":"Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma","enrollment":60},{"nctId":"NCT02860000","phase":"PHASE2","title":"Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2017-07-06","conditions":"Estrogen Receptor Status, HER2/Neu Negative, Invasive Breast Carcinoma","enrollment":96},{"nctId":"NCT01602380","phase":"PHASE3","title":"A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2012-10-17","conditions":"Hormone Receptor Positive Breast Cancer","enrollment":462},{"nctId":"NCT01597388","phase":"PHASE1","title":"AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2012-05-08","conditions":"Advanced Metastatic Breast Cancer","enrollment":99},{"nctId":"NCT02778685","phase":"PHASE2","title":"Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2016-09-30","conditions":"Metastatic Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7","enrollment":47},{"nctId":"NCT07426822","phase":"PHASE2","title":"Rash & Diarrhea Prophylaxis With Capivasertib","status":"NOT_YET_RECRUITING","sponsor":"Maryam Lustberg","startDate":"2026-04","conditions":"Metastatic HR+/HER2- Breast Cancer","enrollment":108},{"nctId":"NCT03179904","phase":"PHASE2","title":"TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mayo Clinic","startDate":"2017-08-03","conditions":"Advanced Breast Carcinoma, HER2-Positive Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8","enrollment":17},{"nctId":"NCT04059484","phase":"PHASE2","title":"Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer","status":"TERMINATED","sponsor":"Sanofi","startDate":"2019-10-22","conditions":"Breast Cancer Metastatic","enrollment":367},{"nctId":"NCT07408089","phase":"PHASE1","title":"Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Boundless Bio, Inc.","startDate":"2026-02-25","conditions":"Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer","enrollment":96},{"nctId":"NCT06494150","phase":"PHASE2","title":"Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)","status":"RECRUITING","sponsor":"University of Oklahoma","startDate":"2024-12-26","conditions":"Low Grade Ovarian Serous Adenocarcinoma","enrollment":37},{"nctId":"NCT07288359","phase":"PHASE1, PHASE2","title":"Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-12-29","conditions":"Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer","enrollment":205},{"nctId":"NCT05022342","phase":"","title":"Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-10-27","conditions":"Breast Cancer","enrollment":595},{"nctId":"NCT07008963","phase":"","title":"Interview of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2025-07-31","conditions":"Metastatic Breast Cancer","enrollment":48},{"nctId":"NCT04546009","phase":"PHASE3","title":"A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-10-09","conditions":"Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer","enrollment":992},{"nctId":"NCT05038735","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2021-12-17","conditions":"Breast Cancer","enrollment":212},{"nctId":"NCT07227233","phase":"PHASE2","title":"Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2026-04","conditions":"Breast Cancer","enrollment":105},{"nctId":"NCT06105632","phase":"PHASE2","title":"A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2024-01-09","conditions":"Advanced or Metastatic Breast Cancer","enrollment":333},{"nctId":"NCT02947685","phase":"PHASE3","title":"Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alliance Foundation Trials, LLC.","startDate":"2017-06-21","conditions":"HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer","enrollment":518},{"nctId":"NCT05101564","phase":"PHASE2","title":"Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer","status":"COMPLETED","sponsor":"Jennifer Lee Caswell-Jin","startDate":"2023-03-20","conditions":"Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer","enrollment":19},{"nctId":"NCT06995482","phase":"PHASE1","title":"Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers","status":"RECRUITING","sponsor":"Kashiv BioSciences, LLC","startDate":"2025-08-18","conditions":"Healthy Postmenopausal Women","enrollment":40},{"nctId":"NCT05985655","phase":"PHASE1, PHASE2","title":"Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.","startDate":"2023-07-06","conditions":"Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC)","enrollment":230},{"nctId":"NCT02624973","phase":"PHASE2","title":"PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Haukeland University Hospital","startDate":"2016-04-15","conditions":"Breast Cancer","enrollment":200},{"nctId":"NCT06585969","phase":"PHASE3","title":"A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer","status":"WITHDRAWN","sponsor":"Danish Breast Cancer Cooperative Group","startDate":"2026-01-01","conditions":"Metastatic Breast Cancer, ER-positive Breast Cancer, Luminal B","enrollment":""},{"nctId":"NCT06135714","phase":"PHASE3","title":"Metastasis-directed Therapy for Oligometastases of Breast Cancer","status":"RECRUITING","sponsor":"Tokyo Medical and Dental University","startDate":"2023-11-08","conditions":"Breast Cancer, Oligometastasis, Metastatic Breast Cancer","enrollment":340},{"nctId":"NCT02499146","phase":"PHASE1","title":"Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-09-11","conditions":"Advanced Breast Cancer","enrollment":26},{"nctId":"NCT05238922","phase":"PHASE1","title":"Study of INCB123667 in Subjects With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Incyte Corporation","startDate":"2022-07-05","conditions":"Solid Tumors","enrollment":604},{"nctId":"NCT05909397","phase":"PHASE3","title":"Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2023-08-09","conditions":"Breast Cancer","enrollment":59},{"nctId":"NCT05501886","phase":"PHASE3","title":"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Celcuity Inc","startDate":"2022-12-08","conditions":"Breast Cancer","enrollment":701},{"nctId":"NCT04923542","phase":"PHASE1, PHASE2","title":"Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2021-11-30","conditions":"Brain Metastases, HR+ Metastatic Breast Cancer","enrollment":31},{"nctId":"NCT07393321","phase":"PHASE3","title":"A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Nanjing Chia-tai Tianqing Pharmaceutical","startDate":"2026-02-10","conditions":"HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer","enrollment":210},{"nctId":"NCT02763566","phase":"PHASE3","title":"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2016-12-05","conditions":"Breast Cancer","enrollment":463},{"nctId":"NCT05646862","phase":"PHASE3","title":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2023-06-07","conditions":"Breast Cancer","enrollment":420},{"nctId":"NCT06757634","phase":"PHASE3","title":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","status":"RECRUITING","sponsor":"Celcuity Inc","startDate":"2025-07-24","conditions":"Breast Cancer","enrollment":674},{"nctId":"NCT05161195","phase":"PHASE4","title":"Roll-over Study to Allow Continued Access to Ribociclib","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2022-07-07","conditions":"Metastatic Breast Cancer","enrollment":134},{"nctId":"NCT05306340","phase":"PHASE3","title":"A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genentech, Inc.","startDate":"2022-08-03","conditions":"Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer","enrollment":373},{"nctId":"NCT07178743","phase":"","title":"Emulation of the PALOMA-2 Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2025-07-14","conditions":"Advanced Breast Cancer","enrollment":6097},{"nctId":"NCT04305496","phase":"PHASE3","title":"Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2020-04-16","conditions":"Locally Advanced (Inoperable) or Metastatic Breast Cancer","enrollment":818},{"nctId":"NCT04650581","phase":"PHASE3","title":"Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Canadian Cancer Trials Group","startDate":"2021-01-27","conditions":"Breast Cancer","enrollment":250},{"nctId":"NCT05305924","phase":"PHASE2","title":"Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer","status":"RECRUITING","sponsor":"The Methodist Hospital Research Institute","startDate":"2021-02-25","conditions":"ER-Positive Breast Cancer, HER2-negative Breast Cancer","enrollment":28},{"nctId":"NCT03781063","phase":"PHASE2","title":"Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","status":"COMPLETED","sponsor":"Sermonix Pharmaceuticals Inc.","startDate":"2019-09-20","conditions":"Locally Advanced or Metastatic Breast Cancer","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2870,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Ibrance","Femara","Faslodex"],"phase":"phase_3","status":"active","brandName":"Palbociclib + Letrozole OR Fulvestrant","genericName":"Palbociclib + Letrozole OR Fulvestrant","companyName":"SOLTI Breast Cancer Research Group","companyId":"solti-breast-cancer-research-group","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Palbociclib inhibits cyclin-dependent kinases 4 and 6 to block cell cycle progression, combined with either letrozole (aromatase inhibitor) or fulvestrant (estrogen receptor antagonist) to suppress hormone-driven breast cancer growth. Used for Hormone receptor-positive, HER2-negative metastatic or advanced breast cancer (first-line or subsequent lines, depending on trial arm).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}