Therapy Detail

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Therapy Name Fulvestrant + Palbociclib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fulvestrant Faslodex ICI 182,780 Hormone - Anti-estrogens 25 Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov).
Palbociclib Ibrance PD0332991|PD-0332991 CDK4/6 Inhibitor 13 Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RB1 K240Sfs*22 TP53 R248W Her2-receptor negative breast cancer predicted - resistant Fulvestrant + Palbociclib Case Reports/Case Series Actionable In a clinical case study, RB1 K240Sfs*22 and TP53 R248W were identified in the circulating tumor DNA of a patient with estrogen receptor positive, progesterone receptor positive, and Erbb2 (Her2)-negative, invasive ductal carcinoma at the time of disease progression after 5 months of Ibrance (palbociclib) and Faslodex (fulvestrant) combination treatment (PMID: 29236940). 29236940
RB1 I101fs RB1 E268* RB1 V654fs RB1 T738_R775del Her2-receptor negative breast cancer predicted - resistant Fulvestrant + Palbociclib Case Reports/Case Series Actionable In a clinical case study, RB1 mutations including E268*, I101fs, T738_R775del, and V654fs were identified in the circulating tumor DNA of a patient with estrogen receptor positive, progesterone receptor positive, and Erbb2 (Her2)-negative, invasive ductal carcinoma at the time of disease progression after 8 months of Ibrance (palbociclib) and Faslodex (fulvestrant) combination treatment (PMID: 29236940). 29236940

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03322215 Phase II Capecitabine Fulvestrant + Palbociclib HR+/HER2- Advanced Breast Cancer and Endocrine Resistance (PASIPHAE) Terminated GBR 1
NCT05826964 Phase II Everolimus + Fulvestrant Exemestane + Ribociclib Everolimus + Tamoxifen Fulvestrant + Ribociclib Everolimus + Exemestane Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Alpelisib + Letrozole Abemaciclib + Exemestane Fulvestrant + Palbociclib Alpelisib + Fulvestrant Letrozole + Palbociclib Exemestane + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Fulvestrant Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer Recruiting USA 0
NCT04862663 Phase III Capivasertib + Fulvestrant + Ribociclib Abemaciclib + Capivasertib + Fulvestrant Capivasertib + Fulvestrant + Palbociclib Fulvestrant + Palbociclib Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) (CAPItello-292) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 14
NCT04985266 Phase II Exemestane + Tamoxifen Fulvestrant + Palbociclib Anastrozole + Tamoxifen Letrozole + Tamoxifen 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 (TRAK-ER) Recruiting GBR | FRA 0
NCT03531645 Phase II Fulvestrant + Palbociclib Fulvestrant Plus Palbociclib in Women With Advanced Low Grade Serous Carcinoma Active, not recruiting USA 0
NCT06065748 Phase III Fulvestrant + Palbociclib Abemaciclib + Fulvestrant Giredestrant + Ribociclib Giredestrant + Palbociclib Abemaciclib + Giredestrant Fulvestrant + Ribociclib 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) Recruiting USA | NZL | ITA | FRA | ESP | DEU | CAN | BEL | AUS 16
NCT05207709 Phase III Letrozole + Ribociclib Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Paclitaxel Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype (HARMONIA) Recruiting USA | ESP 1
NCT02760030 Phase II Fulvestrant + Palbociclib Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery Recruiting USA 0
NCT05226871 Phase II Letrozole + Palbociclib Cetuximab + Palbociclib Cetuximab Fulvestrant + Palbociclib Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies Recruiting USA 3
NCT02913430 Phase II Fulvestrant + Palbociclib Palbociclib + Tamoxifen Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib Unknown status USA 0
NCT04920708 Phase II Fulvestrant + Ribociclib Fulvestrant + Ipatasertib + Palbociclib Fulvestrant + Palbociclib Abemaciclib + Fulvestrant Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (FAIM) Recruiting GBR 0
NCT04256941 Phase II Abemaciclib + Fulvestrant Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Abemaciclib + Letrozole Anastrozole + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Anastrozole Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study Completed USA 0
NCT04191499 Phase II Fulvestrant + Palbociclib Fulvestrant + Inavolisib + Palbociclib A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) Active, not recruiting USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 18
NCT04060862 Phase III Fulvestrant + Ipatasertib + Palbociclib Fulvestrant + Palbociclib A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer (IPATunity150) Terminated USA | GBR | ESP | CAN | AUS 3
NCT03355157 FDA approved Exemestane + Palbociclib Tamoxifen Paclitaxel Exemestane Capecitabine Palbociclib + Tamoxifen Epirubicin Vinorelbine Fulvestrant + Palbociclib Fulvestrant Letrozole Letrozole + Palbociclib 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). (PADMA) Unknown status DEU 0
NCT03007979 Phase II Goserelin Fulvestrant + Palbociclib Letrozole + Palbociclib Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer Completed USA 0
NCT02692755 Phase II Fulvestrant + Palbociclib Letrozole + Palbociclib Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA) Completed USA 0
NCT02384239 Phase II Fulvestrant + Palbociclib Palbociclib + Tamoxifen A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer Completed USA 0
NCT02738866 Phase II Fulvestrant + Palbociclib Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor Active, not recruiting USA 0
NCT04567420 Phase II Fulvestrant + Palbociclib DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer (DARE) Recruiting USA 0
NCT03809988 Phase II Fulvestrant Fulvestrant + Palbociclib Letrozole Letrozole + Palbociclib PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) Completed ITA | GBR | FRA | ESP | DEU 1
NCT03439735 Phase II Palbociclib Fulvestrant + Palbociclib Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC Recruiting USA 0
NCT03691493 Phase II Letrozole + Palbociclib Palbociclib + Tamoxifen Fulvestrant + Palbociclib Anastrozole + Palbociclib Exemestane + Palbociclib Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis (ASPIRE) Completed USA 0
NCT03147287 Phase II Palbociclib Fulvestrant + Palbociclib Avelumab + Fulvestrant + Palbociclib Fulvestrant Palbociclib After CDK and Endocrine Therapy (PACE) Active, not recruiting USA 0


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