{"id":"palbociclib-aromatase-inhibitor","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT04498481","NCT04916509","NCT06307457","NCT03820830","NCT02630693","NCT04985266","NCT00721409","NCT03854903","NCT02028507","NCT02738866","NCT06086340","NCT03870919","NCT03220178","NCT04483505","NCT03079011","NCT02894398","NCT06495164","NCT05012644","NCT02296801","NCT04654208","NCT06624020","NCT02040857","NCT01723774","NCT05043506","NCT05361655"],"aliases":[],"patents":[],"pricing":[],"allNames":"palbociclib + aromatase inhibitor","offLabel":[],"timeline":[{"date":"2013","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-) — 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":"2023","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.) — Breast Cancer Metastatic"}],"aiSummary":"Palbociclib combined with an aromatase inhibitor is a CDK4/6 inhibitor plus hormone therapy used for hormone receptor-positive, HER2-negative advanced breast cancer. Palbociclib blocks cell cycle progression while the aromatase inhibitor reduces estrogen production, providing complementary mechanisms to slow cancer growth. This combination significantly improves progression-free survival compared to hormone therapy alone.","brandName":"Palbociclib + aromatase inhibitor","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"Palbociclib + aromatase inhibitor","explanation":"Cancer cells grow by moving through distinct phases of the cell cycle, controlled by proteins called CDK4 and CDK6. Palbociclib works by blocking these proteins, essentially putting cancer cells in a holding pattern and preventing them from progressing to the next division phase. This slows or stops the cancer's ability to multiply.\n\nAromatase inhibitors work by a different mechanism—they reduce the body's estrogen production. Many breast cancers depend on estrogen to grow, so lowering estrogen starves these cancer cells of a critical growth signal. By using both drugs together, they attack the cancer from two angles: stopping cell division directly while also removing one of the main fuels that drives growth.\n\nThis combination is particularly effective in hormone receptor-positive, HER2-negative breast cancers, which have receptors on their surface that respond to estrogen. The pairing of a direct cell-cycle inhibitor with hormone suppression has proven more effective than either approach alone, helping delay disease progression and improve outcomes for patients with advanced breast cancer.","oneSentence":"Palbociclib + aromatase inhibitor","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"palbociclib-aromatase-inhibitor","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Metastatic Breast Cancer","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"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":"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":"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":"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":"NCT00721409","phase":"Phase 2","title":"Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":177,"indication":"Breast Cancer","completionDate":"2013-11","primaryEndpoint":"The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer"},{"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":"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":"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":"NCT06086340","phase":"N/A","title":"Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":779,"indication":"Breast Cancer","completionDate":"2024-01","primaryEndpoint":"A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI"},{"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":"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"},{"nctId":"NCT02894398","phase":"Phase 2","title":"Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant","status":"Completed","sponsor":"iOMEDICO AG","isPivotal":false,"enrollment":388,"indication":"Breast Cancer","completionDate":"2023-02","primaryEndpoint":"The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who"},{"nctId":"NCT06495164","phase":"N/A","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","isPivotal":false,"enrollment":1,"indication":"Breast Cancer","completionDate":"2026-12","primaryEndpoint":"Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human e"},{"nctId":"NCT05012644","phase":"N/A","title":"Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated Wi","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":197,"indication":"Metastatic Breast Cancer","completionDate":"2021-12","primaryEndpoint":"This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line "},{"nctId":"NCT02296801","phase":"Phase 2","title":"A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Pal","status":"Completed","sponsor":"NSABP Foundation Inc","isPivotal":false,"enrollment":307,"indication":"Breast Cancer","completionDate":"2018-07","primaryEndpoint":"This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors w"},{"nctId":"NCT04654208","phase":"N/A","title":"Swedish Ibrance Registries Insights (SIRI)","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":1500,"indication":"Malignant Neoplasm of Breast","completionDate":"2025-12","primaryEndpoint":"The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice."},{"nctId":"NCT06624020","phase":"N/A","title":"A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Me","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1128,"indication":"Breast Neoplasms","completionDate":"2024-07","primaryEndpoint":"The purpose of this study is to learn about how a class of medicines called CDK4/6 inhibitors, are used for the treatment of breast cancer in patients in Australia."},{"nctId":"NCT02040857","phase":"Phase 2","title":"Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negat","status":"Completed","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":162,"indication":"Breast Cancer","completionDate":"2018-05","primaryEndpoint":"This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer."},{"nctId":"NCT01723774","phase":"Phase 2","title":"PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Canc","status":"Active Not Recruiting","sponsor":"Washington University School of Medicine","isPivotal":false,"enrollment":84,"indication":"Breast Neoplasms","completionDate":"2021-04","primaryEndpoint":"A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combi"},{"nctId":"NCT05043506","phase":"N/A","title":"European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal T","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1939,"indication":"Metastatic Breast Cancer","completionDate":"2023-11","primaryEndpoint":"A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI a"},{"nctId":"NCT05361655","phase":"N/A","title":"Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":2888,"indication":"Metastatic Breast Cancer","completionDate":"2021-09","primaryEndpoint":"A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palb"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL2364621"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":2,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}