{"id":"palbociclib-plus-fulvestrant","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT03424005","NCT04498481","NCT04916509","NCT04920708","NCT04671615","NCT07174336","NCT03447132","NCT03147287","NCT03820830","NCT07096024","NCT04606446","NCT02630693","NCT04985266","NCT06525675","NCT04553133","NCT03854903","NCT03921866","NCT02028507","NCT03809988","NCT02738866","NCT02389842","NCT03007979","NCT03220178","NCT04483505","NCT03079011"],"aliases":[],"patents":[],"pricing":[],"allNames":"palbociclib plus fulvestrant","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":"2018","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib) — Advanced Solid Tumours"},{"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."}],"aiSummary":"Palbociclib, a small molecule, is used in combination with fulvestrant to treat various types of breast cancer, including metastatic, advanced, luminal, HER2-negative, and ER-positive breast cancer. The combination of palbociclib and fulvestrant has been studied in clinical trials, such as the PARSIFAL study, to evaluate its efficacy and safety in these patient populations.","brandName":"palbociclib plus fulvestrant","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Patients treated with the combination of palbociclib and fulvestrant","explanation":"This combination works by attacking hormone-sensitive breast cancer on two fronts. Palbociclib is a small molecule that inhibits CDK4 and CDK6 proteins, which are essential for pushing cells through their division cycle. By blocking these proteins, palbociclib essentially puts the brakes on cell division, causing cancer cells to pause their growth.\n\nFulvestrant takes a different approach by acting as an estrogen receptor antagonist. In hormone receptor-positive breast cancers, estrogen binds to receptors on the cancer cell surface and sends signals telling the cell to grow and divide. Fulvestrant blocks these receptors and actually causes them to degrade, eliminating the cancer cell's ability to respond to estrogen signals.\n\nTogether, these two drugs create a more powerful treatment: palbociclib directly halts the cell division machinery while fulvestrant removes the hormone signal that was driving growth in the first place. This combination approach is particularly effective for advanced breast cancers that have stopped responding to hormone therapy alone, offering patients a more durable treatment response.","oneSentence":"Patients treated with the combination of palbociclib and fulvestrant","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"palbociclib-plus-fulvestrant","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Breast Neoplasms","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03424005","phase":"Phase 1/2","title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metas","status":"Recruiting","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":792,"indication":"Metastatic Breast Cancer","completionDate":"2030-09","primaryEndpoint":"This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer."},{"nctId":"NCT04498481","phase":"N/A","title":"TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATIO","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1,"indication":"Breast Cancer","completionDate":"2018-07","primaryEndpoint":"This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combinat"},{"nctId":"NCT04916509","phase":"N/A","title":"Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormo","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":258,"indication":"Breast Neoplasms","completionDate":"2022-12","primaryEndpoint":"retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the t"},{"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":"NCT04671615","phase":"N/A","title":"A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":559,"indication":"Metastatic Breast Cancer","completionDate":"2022-11","primaryEndpoint":"The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel."},{"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":"NCT03447132","phase":"Phase 3","title":"Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant","status":"Completed","sponsor":"International Cancer Research Group, United Arab Emirates","isPivotal":false,"enrollment":354,"indication":"Breast Neoplasm Female","completionDate":"2021-04","primaryEndpoint":"This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the co"},{"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":"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":"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":"NCT03854903","phase":"Phase 1","title":"WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to ","status":"Completed","sponsor":"Georgetown University","isPivotal":false,"enrollment":19,"indication":"Metastatic Breast Cancer","completionDate":"2023-11","primaryEndpoint":"This is an open-label, single-arm, phase I trial."},{"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":"NCT02389842","phase":"Phase 1","title":"PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib","status":"Completed","sponsor":"Royal Marsden NHS Foundation Trust","isPivotal":false,"enrollment":79,"indication":"Advanced Solid Tumours","completionDate":"2018-10","primaryEndpoint":"Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K inhibitors taselisib, or pictilisib."},{"nctId":"NCT03007979","phase":"Phase 2","title":"Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer","status":"Completed","sponsor":"Washington University School of Medicine","isPivotal":false,"enrollment":55,"indication":"Breast Cancer","completionDate":"2020-03","primaryEndpoint":"The investigators propose to conduct a study to test an alternative dosing schedule of palbociclib."},{"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 "},{"nctId":"NCT04483505","phase":"Phase 1","title":"Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.","status":"Completed","sponsor":"Fundacion CRIS de Investigación para Vencer el Cáncer","isPivotal":false,"enrollment":9,"indication":"Breast Cancer Metastatic","completionDate":"2023-04","primaryEndpoint":"This study is an open, multicenter, prospective phase I dose escalation clinical trial followed by an expansion cohort."},{"nctId":"NCT03079011","phase":"Phase 3","title":"PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection","status":"Completed","sponsor":"UNICANCER","isPivotal":false,"enrollment":1017,"indication":"Metastatic Breast Cancer","completionDate":"2021-04","primaryEndpoint":"This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2"}],"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":3,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}