{"id":"palbociclib-endocrine-therapy","rwe":[{"pmid":"40796258","year":"2025","title":"Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis.","journal":"JNCI cancer spectrum"},{"pmid":"40553419","year":"2025","title":"Relationship of Prior Anticancer Treatments with Palbociclib Clinical Outcomes in Patients with HR(+)/HER2(-) Advanced Breast Cancer in Real-World Settings.","journal":"Targeted oncology"},{"pmid":"39754986","year":"2025","title":"Drug-drug interactions between palbociclib and proton pump inhibitors in early breast cancer: an exploratory analysis of PALLAS (ABCSG-42/AFT-05/BIG-14-13/PrE0109).","journal":"ESMO open"},{"pmid":"39475418","year":"2025","title":"Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer: final results from the POLARIS trial.","journal":"The oncologist"}],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT03819010","NCT01864746","NCT03454035","NCT04920708","NCT02871791","NCT06307457","NCT07174336","NCT03147287","NCT03820830","NCT03644186","NCT06760637","NCT07096024","NCT04606446","NCT02630693","NCT02774681","NCT04985266","NCT06525675","NCT04553133","NCT03921866","NCT02028507","NCT03809988","NCT02738866","NCT03870919","NCT03609047","NCT03220178"],"aliases":[],"patents":[],"pricing":[],"allNames":"palbociclib + endocrine therapy","offLabel":[],"timeline":[{"date":"2018","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive) — Breast Cancer"},{"date":"2019","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Ar) — Metastatic Breast Cancer"},{"date":"2021","type":"negative","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbo) — Breast Neoplasm. Trial terminated early."},{"date":"2026","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors) — Tumor, Solid"}],"aiSummary":"Palbociclib is a small molecule used in combination with endocrine therapy, such as tamoxifen or aromatase inhibitors, to treat hormone receptor-positive breast cancer. This combination is studied in various clinical trials, including those for early-stage, advanced, and hormone receptor-positive breast cancer.","brandName":"Palbociclib + endocrine therapy","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib +","explanation":"Palbociclib works by inhibiting two proteins called CDK4 and CDK6, which act as molecular \"keys\" that allow breast cancer cells to progress through their growth cycle. By blocking these proteins, palbociclib essentially puts the brakes on cell division, trapping cancer cells in a resting phase where they cannot multiply. This gives the endocrine therapy (hormone-blocking drugs like tamoxifen or aromatase inhibitors) more time to work against the cancer.\n\nEndocrine therapy targets the estrogen receptor on hormone-responsive breast cancer cells, either by blocking estrogen production or by preventing estrogen from attaching to cancer cells. While endocrine therapy alone can slow cancer growth, many tumors eventually develop resistance. By combining it with palbociclib, which attacks a different part of the cancer cell's growth machinery, the two drugs work synergistically—they tackle cancer growth from multiple angles simultaneously.\n\nThis combination approach has proven particularly effective in advanced breast cancer that has spread beyond the breast, where it extends the time before the cancer progresses and improves overall survival compared to endocrine therapy alone. The dual mechanism helps overcome some of the resistance mechanisms that allow cancers to escape single-drug treatments.","oneSentence":"Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib +","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"palbociclib-endocrine-therapy","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Breast Neoplasms","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03819010","phase":"Phase 2","title":"Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -","status":"Completed","sponsor":"MedSIR","isPivotal":false,"enrollment":66,"indication":"Breast Cancer","completionDate":"2019-07","primaryEndpoint":"This is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial."},{"nctId":"NCT01864746","phase":"Phase 3","title":"A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2","status":"Completed","sponsor":"GBG Forschungs GmbH","isPivotal":false,"enrollment":1250,"indication":"Breast Cancer","completionDate":"2020-08","primaryEndpoint":"The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre"},{"nctId":"NCT03454035","phase":"Phase 1","title":"Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors","status":"Recruiting","sponsor":"UNC Lineberger Comprehensive Cancer Center","isPivotal":false,"enrollment":45,"indication":"Tumor, Solid","completionDate":"2026-07","primaryEndpoint":"This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inh"},{"nctId":"NCT04920708","phase":"Phase 2","title":"Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Withou","status":"Recruiting","sponsor":"Royal Marsden NHS Foundation Trust","isPivotal":false,"enrollment":324,"indication":"Metastatic Breast Cancer","completionDate":"2026-09","primaryEndpoint":"Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy."},{"nctId":"NCT02871791","phase":"Phase 1/2","title":"Palbociclib With Everolimus + Exemestane In BC","status":"Completed","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":41,"indication":"Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","completionDate":"2020-12","primaryEndpoint":"This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor pos"},{"nctId":"NCT06307457","phase":"N/A","title":"A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aro","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":604,"indication":"Breast Cancer","completionDate":"2024-04","primaryEndpoint":"The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer."},{"nctId":"NCT07174336","phase":"Phase 3","title":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Adv","status":"Recruiting","sponsor":"Eli Lilly and Company","isPivotal":false,"enrollment":920,"indication":"Breast Neoplasms","completionDate":"2029-05","primaryEndpoint":"The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR"},{"nctId":"NCT03147287","phase":"Phase 2","title":"Palbociclib After CDK and Endocrine Therapy (PACE)","status":"Active Not Recruiting","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":220,"indication":"Metastatic Breast Cancer","completionDate":"2022-12","primaryEndpoint":"This research study is studying three combinations of drugs as treatments for breast cancer."},{"nctId":"NCT03820830","phase":"Phase 3","title":"Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer","status":"Active Not Recruiting","sponsor":"ETOP IBCSG Partners Foundation","isPivotal":false,"enrollment":405,"indication":"Breast Cancer Recurrent","completionDate":"2026-01","primaryEndpoint":"POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer."},{"nctId":"NCT03644186","phase":"Phase 2","title":"To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Brea","status":"Completed","sponsor":"ETOP IBCSG Partners Foundation","isPivotal":false,"enrollment":147,"indication":"Breast Cancer","completionDate":"2023-01","primaryEndpoint":"This is a phase II open-label, multicentre, randomized trial."},{"nctId":"NCT06760637","phase":"Phase 3","title":"Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have ","status":"Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":1020,"indication":"Breast Cancer","completionDate":"2029-01","primaryEndpoint":"The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people wi"},{"nctId":"NCT07096024","phase":"N/A","title":"A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1772,"indication":"Breast Neoplasms","completionDate":"2025-02","primaryEndpoint":"The purpose of the study is to: * compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before "},{"nctId":"NCT04606446","phase":"Phase 1","title":"Study of PF-07248144 in Advanced or Metastatic Solid Tumors","status":"Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":320,"indication":"Locally Advanced or Metastatic ER+ HER2- Breast Cancer","completionDate":"2028-02","primaryEndpoint":"This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a sin"},{"nctId":"NCT02630693","phase":"Phase 2","title":"Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive","status":"Completed","sponsor":"Canadian Cancer Trials Group","isPivotal":false,"enrollment":180,"indication":"Breast Cancer","completionDate":"2018-08","primaryEndpoint":"The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions th"},{"nctId":"NCT02774681","phase":"Phase 2","title":"Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis","status":"Terminated","sponsor":"Northwestern University","isPivotal":false,"enrollment":12,"indication":"Breast Carcinoma Metastatic in the Brain","completionDate":"2019-02","primaryEndpoint":"The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic res"},{"nctId":"NCT04985266","phase":"Phase 2","title":"A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment W","status":"Recruiting","sponsor":"Royal Marsden NHS Foundation Trust","isPivotal":false,"enrollment":1100,"indication":"ER+ Breast Cancer","completionDate":"2027-09","primaryEndpoint":"Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy."},{"nctId":"NCT06525675","phase":"N/A","title":"Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Stu","status":"Completed","sponsor":"MedSIR","isPivotal":false,"enrollment":419,"indication":"Metastatic Breast Cancer","completionDate":"2024-05","primaryEndpoint":"The goal of this study is to evaluate the extended Overall Survival (OS) from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozol"},{"nctId":"NCT04553133","phase":"Phase 2","title":"PF-07104091 as a Single Agent and in Combination Therapy","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":154,"indication":"Small Cell Lung Cancer","completionDate":"2026-03","primaryEndpoint":"To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single "},{"nctId":"NCT03921866","phase":"N/A","title":"UK Ibrance Patient Program (IPP) Study","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":191,"indication":"HR+/HER2- Locally Advanced, Metastatic Breast Cancer","completionDate":"2021-03","primaryEndpoint":"What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation i"},{"nctId":"NCT02028507","phase":"Phase 3","title":"Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Ar","status":"Completed","sponsor":"Spanish Breast Cancer Research Group","isPivotal":false,"enrollment":693,"indication":"Metastatic Breast Cancer","completionDate":"2019-01","primaryEndpoint":"This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg da"},{"nctId":"NCT03809988","phase":"Phase 2","title":"PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)","status":"Completed","sponsor":"MedSIR","isPivotal":false,"enrollment":198,"indication":"Breast Cancer","completionDate":"2022-11","primaryEndpoint":"Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)"},{"nctId":"NCT02738866","phase":"Phase 2","title":"Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Ar","status":"Active Not Recruiting","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","isPivotal":false,"enrollment":60,"indication":"Metastatic Breast Cancer","completionDate":"2026-06","primaryEndpoint":"This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combinat"},{"nctId":"NCT03870919","phase":"N/A","title":"Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cance","status":"Active Not Recruiting","sponsor":"UNICANCER","isPivotal":false,"enrollment":200,"indication":"Breast Cancer Stage IV","completionDate":"2024-08","primaryEndpoint":"Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic."},{"nctId":"NCT03609047","phase":"Phase 2","title":"Adjuvant Palbociclib in Elderly Patients With Breast Cancer","status":"Active Not Recruiting","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","isPivotal":false,"enrollment":366,"indication":"Breast Cancer Stage II","completionDate":"2026-06","primaryEndpoint":"Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocri"},{"nctId":"NCT03220178","phase":"Phase 4","title":"Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbo","status":"Terminated","sponsor":"Palleos Healthcare GmbH","isPivotal":false,"enrollment":532,"indication":"Breast Neoplasm","completionDate":"2021-12","primaryEndpoint":"In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer "}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL2364621"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":6,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}