{"id":"palbociclib-letrozole","safety":{"commonSideEffects":[{"rate":"30-40%","effect":"Fatigue"},{"rate":"20-30%","effect":"Nausea"},{"rate":"20-30%","effect":"Diarrhea"},{"rate":"10-20%","effect":"Vomiting"},{"rate":"10-20%","effect":"Leukopenia"},{"rate":"10-20%","effect":"Neutropenia"},{"rate":"5-10%","effect":"Thrombocytopenia"},{"rate":"5-10%","effect":"Anemia"}]},"_chembl":{"chemblId":"CHEMBL1444","moleculeType":"Small molecule","molecularWeight":"285.31"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Palbociclib works by inhibiting the cyclin-dependent kinases 4 and 6 (CDK4/6), which are involved in cell cycle progression. This leads to cell cycle arrest and apoptosis in cancer cells. Letrozole, on the other hand, inhibits the enzyme aromatase, which is responsible for converting androgens to estrogens. By reducing estrogen levels, Letrozole can help slow the growth of hormone receptor-positive breast cancer cells.","oneSentence":"Palbociclib is a CDK4/6 inhibitor that blocks the cell cycle, while Letrozole is an aromatase inhibitor that reduces estrogen levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:25:23.343Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer"}]},"trialDetails":[{"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"NCT04964934","phase":"PHASE3","title":"Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2021-06-30","conditions":"ER-Positive HER2-Negative Breast Cancer","enrollment":315},{"nctId":"NCT07340658","phase":"PHASE3","title":"A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Palbociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Advanced Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Rovi Pharmaceuticals Laboratories","startDate":"2026-05","conditions":"Advanced, Metastatic Breast Cancer","enrollment":300},{"nctId":"NCT05826964","phase":"PHASE2","title":"Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Miami","startDate":"2023-06-12","conditions":"Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer","enrollment":24},{"nctId":"NCT05069038","phase":"PHASE2","title":"Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Nebraska","startDate":"2022-03-02","conditions":"Breast Cancer","enrollment":51},{"nctId":"NCT04563507","phase":"PHASE2","title":"Combined Immunotherapies in Metastatic ER+ Breast Cancer","status":"RECRUITING","sponsor":"Weill Medical College of Cornell University","startDate":"2020-11-12","conditions":"Breast Cancer","enrollment":102},{"nctId":"NCT04735367","phase":"","title":"Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-02-03","conditions":"Breast Cancer","enrollment":42},{"nctId":"NCT05226871","phase":"PHASE2","title":"Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2022-07-07","conditions":"Breast Cancer, Head and Neck Cancer","enrollment":35},{"nctId":"NCT06495164","phase":"","title":"A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2024-06-24","conditions":"Breast Cancer, Malignant Neoplasm of Breast","enrollment":1},{"nctId":"NCT05867251","phase":"PHASE1, PHASE2","title":"Study of AVZO-021 in Patients With Advanced Solid Tumors","status":"RECRUITING","sponsor":"Avenzo Therapeutics, Inc.","startDate":"2023-08-30","conditions":"Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer","enrollment":430},{"nctId":"NCT06086340","phase":"","title":"Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-09-29","conditions":"Breast Cancer","enrollment":779},{"nctId":"NCT07180160","phase":"PHASE2","title":"Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer","status":"RECRUITING","sponsor":"Wenjin Yin","startDate":"2025-09-25","conditions":"Advanced Breast Cancer","enrollment":123},{"nctId":"NCT03079011","phase":"PHASE3","title":"PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection","status":"COMPLETED","sponsor":"UNICANCER","startDate":"2017-03-22","conditions":"Metastatic Breast Cancer","enrollment":1017},{"nctId":"NCT02297438","phase":"PHASE3","title":"A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-03-23","conditions":"Breast Neoplasms","enrollment":340},{"nctId":"NCT03959891","phase":"PHASE1","title":"AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2019-05-30","conditions":"Breast Cancer","enrollment":77},{"nctId":"NCT03425838","phase":"PHASE3","title":"Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Borstkanker Onderzoek Groep","startDate":"2017-11-09","conditions":"Breast Neoplasm Female","enrollment":1050},{"nctId":"NCT06145308","phase":"PHASE2","title":"Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing","status":"RECRUITING","sponsor":"Peking Union Medical College","startDate":"2023-08-15","conditions":"Salivary Gland Carcinoma, Precision Therapy","enrollment":39},{"nctId":"NCT04478266","phase":"PHASE3","title":"Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer","status":"TERMINATED","sponsor":"Sanofi","startDate":"2020-10-14","conditions":"Breast Cancer","enrollment":1068},{"nctId":"NCT04553133","phase":"PHASE2","title":"PF-07104091 as a Single Agent and in Combination Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2020-09-16","conditions":"Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer","enrollment":154},{"nctId":"NCT04606446","phase":"PHASE1","title":"Study of PF-07248144 in Advanced or Metastatic Solid Tumors","status":"RECRUITING","sponsor":"Pfizer","startDate":"2020-11-16","conditions":"Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer","enrollment":320},{"nctId":"NCT02730429","phase":"PHASE2","title":"Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer","status":"COMPLETED","sponsor":"Nordic Society of Gynaecological Oncology - Clinical Trials Unit","startDate":"2017-02-15","conditions":"Endometrial Cancer","enrollment":78},{"nctId":"NCT07061717","phase":"PHASE3","title":"Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2025-07-01","conditions":"Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer","enrollment":474},{"nctId":"NCT04767594","phase":"","title":"First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2020-10-27","conditions":"Breast Neoplasms","enrollment":1409},{"nctId":"NCT06570031","phase":"PHASE1","title":"ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2021-11-09","conditions":"Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer","enrollment":46},{"nctId":"NCT07005557","phase":"PHASE3","title":"Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","startDate":"2025-06-15","conditions":"Breast Cancer, Adjuvant Therapy","enrollment":1244},{"nctId":"NCT02764541","phase":"PHASE2","title":"Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2016-05-24","conditions":"Breast Cancer","enrollment":195},{"nctId":"NCT05190094","phase":"PHASE2","title":"Prediction of Treatment Efficacy of the Combination of Palbociclib/(Letrozole or Anastrozole) in First Line Metastatic Women With Luminal, HER2 Negative Advanced Breast Cancer, Using Infrared Laser Spectroscopy Analysis on Liquid Biopsies.","status":"RECRUITING","sponsor":"International Cancer Research Group, United Arab Emirates","startDate":"2022-12-20","conditions":"Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer","enrollment":80},{"nctId":"NCT02040857","phase":"PHASE2","title":"Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2014-01","conditions":"Breast Cancer","enrollment":162},{"nctId":"NCT05207709","phase":"PHASE3","title":"Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype","status":"ACTIVE_NOT_RECRUITING","sponsor":"SOLTI Breast Cancer Research Group","startDate":"2022-03-28","conditions":"Metastatic Breast Cancer","enrollment":456},{"nctId":"NCT06810492","phase":"NA","title":"The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment","status":"NOT_YET_RECRUITING","sponsor":"Hongmei Zheng, PhD","startDate":"2025-04-01","conditions":"Breast Cancer Stage III, Breast Cancer Stage II","enrollment":40},{"nctId":"NCT03820830","phase":"PHASE3","title":"Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"ETOP IBCSG Partners Foundation","startDate":"2019-08-27","conditions":"Breast Cancer Recurrent","enrollment":405},{"nctId":"NCT03281902","phase":"","title":"Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mayo Clinic","startDate":"2017-11-13","conditions":"Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma","enrollment":68},{"nctId":"NCT03691493","phase":"PHASE2","title":"Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis","status":"COMPLETED","sponsor":"Emory University","startDate":"2019-02-08","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative","enrollment":36},{"nctId":"NCT03774472","phase":"PHASE1, PHASE2","title":"Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2018-08-20","conditions":"Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8","enrollment":15},{"nctId":"NCT04256941","phase":"PHASE2","title":"Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-05-31","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8","enrollment":4},{"nctId":"NCT03644186","phase":"PHASE2","title":"To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)","status":"COMPLETED","sponsor":"ETOP IBCSG Partners Foundation","startDate":"2019-04-16","conditions":"Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer","enrollment":147},{"nctId":"NCT06525675","phase":"","title":"Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)","status":"COMPLETED","sponsor":"MedSIR","startDate":"2022-07-18","conditions":"Metastatic Breast Cancer, Advanced Breast Cancer, Luminal Breast Cancer","enrollment":419},{"nctId":"NCT02491983","phase":"PHASE2","title":"Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer","status":"COMPLETED","sponsor":"MedSIR","startDate":"2015-08","conditions":"Metastatic Breast Cancer","enrollment":486},{"nctId":"NCT04985266","phase":"PHASE2","title":"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","status":"RECRUITING","sponsor":"Royal Marsden NHS Foundation Trust","startDate":"2022-03-30","conditions":"ER+ Breast Cancer, HER2-negative Breast Cancer","enrollment":1100},{"nctId":"NCT06044623","phase":"PHASE3","title":"Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients","status":"RECRUITING","sponsor":"Region Örebro County","startDate":"2024-04-01","conditions":"Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life","enrollment":495},{"nctId":"NCT01740427","phase":"PHASE3","title":"A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-02-22","conditions":"Breast Neoplasms","enrollment":666},{"nctId":"NCT03900884","phase":"PHASE1","title":"Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Peter MacCallum Cancer Centre, Australia","startDate":"2019-09-25","conditions":"Breast Neoplasm Female","enrollment":17},{"nctId":"NCT04460898","phase":"","title":"RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2019-01-04","conditions":"Breast Cancer","enrollment":195},{"nctId":"NCT03355157","phase":"PHASE4","title":"A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).","status":"COMPLETED","sponsor":"GBG Forschungs GmbH","startDate":"2018-03-01","conditions":"Metastatic Breast Cancer","enrollment":130},{"nctId":"NCT06607601","phase":"","title":"CARE Initiative: Real-world Emulation of the PALOMA-2 Trial","status":"COMPLETED","sponsor":"Aetion, Inc.","startDate":"2010-02-01","conditions":"Metastatic Breast Cancer","enrollment":724},{"nctId":"NCT03870919","phase":"NA","title":"Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"UNICANCER","startDate":"2019-10-23","conditions":"Breast Cancer Stage IV, Radiotherapy, Surgery","enrollment":200},{"nctId":"NCT03284723","phase":"PHASE1","title":"PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors","status":"TERMINATED","sponsor":"Pfizer","startDate":"2017-11-01","conditions":"Breast Neoplasms","enrollment":95},{"nctId":"NCT04176354","phase":"","title":"Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy","status":"COMPLETED","sponsor":"Pfizer","startDate":"2019-01-25","conditions":"Metastatic Breast Cancer","enrollment":813},{"nctId":"NCT06176534","phase":"PHASE2","title":"Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial","status":"RECRUITING","sponsor":"Henan Cancer Hospital","startDate":"2024-01-01","conditions":"Advanced Breast Cancer, Treatment, HR Low/HER2 Negative","enrollment":240},{"nctId":"NCT02448420","phase":"PHASE2","title":"Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer","status":"COMPLETED","sponsor":"SOLTI Breast Cancer Research Group","startDate":"2015-07","conditions":"Metastatic Breast Cancer","enrollment":73},{"nctId":"NCT03007979","phase":"PHASE2","title":"Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2017-06-15","conditions":"Breast Cancer, Breast Carcinoma, Cancer of Breast","enrollment":55},{"nctId":"NCT03709082","phase":"PHASE1, PHASE2","title":"Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer","status":"TERMINATED","sponsor":"University of Kansas Medical Center","startDate":"2018-10-15","conditions":"HER2-positive Breast Cancer, Breast Cancer Metastatic","enrollment":3},{"nctId":"NCT03936270","phase":"PHASE2","title":"Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer","status":"COMPLETED","sponsor":"Latin American Cooperative Oncology Group","startDate":"2020-03-05","conditions":"Ovarian Cancer","enrollment":43},{"nctId":"NCT05238831","phase":"EARLY_PHASE1","title":"SMMART Adaptive Clinical Treatment (ACT) Trial","status":"WITHDRAWN","sponsor":"OHSU Knight Cancer Institute","startDate":"2023-01-30","conditions":"Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma","enrollment":""},{"nctId":"NCT03054363","phase":"PHASE1, PHASE2","title":"Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2017-11-27","conditions":"Breast Cancer","enrollment":42},{"nctId":"NCT03809988","phase":"PHASE2","title":"PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)","status":"COMPLETED","sponsor":"MedSIR","startDate":"2019-04-05","conditions":"Breast Cancer, Advanced Breast Cancer, Hormone Receptor Positive Tumor","enrollment":198},{"nctId":"NCT05969184","phase":"PHASE2","title":"Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC","status":"UNKNOWN","sponsor":"Peking University Cancer Hospital & Institute","startDate":"2021-12-25","conditions":"Breast Neoplasm Female","enrollment":94},{"nctId":"NCT04872608","phase":"PHASE1","title":"A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer","status":"WITHDRAWN","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2021-09-09","conditions":"Metastatic Breast Cancer, Unresectable Breast Cancer","enrollment":""},{"nctId":"NCT03065621","phase":"PHASE2","title":"Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA)","status":"COMPLETED","sponsor":"Jules Bordet Institute","startDate":"2017-07-05","conditions":"Breast Cancer Female","enrollment":100},{"nctId":"NCT05766410","phase":"PHASE2","title":"A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2022-09-16","conditions":"Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy","enrollment":60},{"nctId":"NCT02894398","phase":"PHASE2","title":"Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant","status":"COMPLETED","sponsor":"iOMEDICO AG","startDate":"2016-09-06","conditions":"Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","enrollment":388},{"nctId":"NCT03969121","phase":"PHASE3","title":"Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer","status":"COMPLETED","sponsor":"Kyoto Breast Cancer Research Network","startDate":"2019-07-16","conditions":"Breast Cancer Female, Hormone Receptor Positive Malignant Neoplasm of Breast","enrollment":141},{"nctId":"NCT04130152","phase":"EARLY_PHASE1","title":"Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy","status":"COMPLETED","sponsor":"SOLTI Breast Cancer Research Group","startDate":"2019-11-21","conditions":"Breast Cancer","enrollment":22},{"nctId":"NCT02806050","phase":"PHASE2","title":"Palbociclib and FES PET","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2016-09-16","conditions":"Breast Cancer","enrollment":30},{"nctId":"NCT03128619","phase":"PHASE1","title":"Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer","status":"TERMINATED","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2017-08-02","conditions":"Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma","enrollment":10},{"nctId":"NCT02679755","phase":"PHASE4","title":"Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-03-09","conditions":"Breast Cancer","enrollment":252},{"nctId":"NCT02684032","phase":"PHASE1","title":"A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Celcuity Inc","startDate":"2016-06-14","conditions":"Breast Cancer","enrollment":141},{"nctId":"NCT05429684","phase":"PHASE3","title":"Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2021-01-01","conditions":"HER2+ Breast Cancer","enrollment":120},{"nctId":"NCT03184090","phase":"PHASE2","title":"Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC","status":"COMPLETED","sponsor":"MedSIR","startDate":"2017-06-28","conditions":"Metastatic Breast Cancer","enrollment":33},{"nctId":"NCT03628066","phase":"PHASE2","title":"Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer","status":"COMPLETED","sponsor":"NSABP Foundation Inc","startDate":"2018-10-22","conditions":"Breast Cancer","enrollment":24},{"nctId":"NCT02400567","phase":"PHASE2","title":"Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women","status":"COMPLETED","sponsor":"UNICANCER","startDate":"2015-01","conditions":"Neoadjuvant Operable Breast Cancer","enrollment":125},{"nctId":"NCT02600923","phase":"PHASE3","title":"Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-04-15","conditions":"Advanced Breast Cancer Female","enrollment":131},{"nctId":"NCT02296801","phase":"PHASE2","title":"A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer","status":"COMPLETED","sponsor":"NSABP Foundation Inc","startDate":"2015-01","conditions":"Breast Cancer, Breast Carcinoma, Breast Tumors","enrollment":307},{"nctId":"NCT03220178","phase":"PHASE4","title":"Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy","status":"TERMINATED","sponsor":"Palleos Healthcare GmbH","startDate":"2017-07-24","conditions":"Breast Neoplasm","enrollment":532},{"nctId":"NCT03633331","phase":"PHASE2","title":"Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer","status":"UNKNOWN","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2018-08-15","conditions":"Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7","enrollment":93},{"nctId":"NCT02907918","phase":"PHASE2","title":"Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer","status":"TERMINATED","sponsor":"Washington University School of Medicine","startDate":"2017-06-30","conditions":"Breast Cancer, Cancer of Breast, Breast Carcinoma","enrollment":26},{"nctId":"NCT02692755","phase":"PHASE2, PHASE3","title":"Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer","status":"COMPLETED","sponsor":"Georgetown University","startDate":"2016-09","conditions":"Hormone Receptor Positive HER-2 Negative Breast Cancer","enrollment":35},{"nctId":"NCT02603679","phase":"PHASE2","title":"Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases","status":"ACTIVE_NOT_RECRUITING","sponsor":"Thomas Hatschek","startDate":"2015-02","conditions":"Early-Stage Breast Carcinoma, Estrogen Receptor Positive Tumor","enrollment":181},{"nctId":"NCT04137640","phase":"PHASE4","title":"Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy","status":"NOT_YET_RECRUITING","sponsor":"Shengjing Hospital","startDate":"2021-07-19","conditions":"Breast Cancer","enrollment":152},{"nctId":"NCT04047758","phase":"PHASE3","title":"Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer","status":"UNKNOWN","sponsor":"Shengjing Hospital","startDate":"2019-09-01","conditions":"Breast Cancer","enrollment":420},{"nctId":"NCT04856371","phase":"PHASE1","title":"Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer","status":"UNKNOWN","sponsor":"Haihe Biopharma Co., Ltd.","startDate":"2021-04","conditions":"Advanced Breast Cancer","enrollment":228},{"nctId":"NCT04852081","phase":"","title":"Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.","status":"UNKNOWN","sponsor":"Blokhin's Russian Cancer Research Center","startDate":"2021-01-01","conditions":"Breast Cancer Stage IV","enrollment":1000},{"nctId":"NCT03819010","phase":"PHASE2","title":"Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -","status":"COMPLETED","sponsor":"MedSIR","startDate":"2019-05-07","conditions":"Breast Cancer","enrollment":66},{"nctId":"NCT01684215","phase":"PHASE2","title":"A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-10-19","conditions":"Neoplasms, Breast Neoplasms","enrollment":61}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":34,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Palbociclib + Letrozole","genericName":"Palbociclib + Letrozole","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Palbociclib is a CDK4/6 inhibitor that blocks the cell cycle, while Letrozole is an aromatase inhibitor that reduces estrogen levels. Used for Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}