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 18 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 CDK4/6 Inhibitor 10 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 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
PIK3CA H1047R estrogen-receptor positive breast cancer no benefit Fulvestrant + Palbociclib Case Reports/Case Series Actionable In a clinical case study, a metastatic ER-positive, PR-positive, HER2-negative breast cancer patient harboring PIK3CA H1047R and PIK3C2B amplification treated with Faslodex (fulvestrant) in combination with Ibrance (palbociclib) demonstrated disease progression with increased left cerebellar lesion four months following treatment (PMID: 32923889). 32923889

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Recruiting USA 0
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) Recruiting USA | CAN 10
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
NCT02913430 Phase II Fulvestrant + Palbociclib Palbociclib + Tamoxifen Phase II Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib Recruiting USA 0
NCT02692755 Phase II Fulvestrant + Palbociclib Letrozole + Palbociclib Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA) Active, not recruiting USA 0
NCT03007979 Phase II Goserelin Fulvestrant + Palbociclib Letrozole + Palbociclib Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer Active, not recruiting USA 0
NCT02760030 Phase II Fulvestrant + Palbociclib Fulvestrant or Aromatase Inhibitor and Palbociclib in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery Recruiting USA 0
NCT03147287 Phase II Palbociclib Fulvestrant + Palbociclib Avelumab + Fulvestrant + Palbociclib Fulvestrant Palbociclib After CDK and Endocrine Therapy (PACE) 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
NCT02738866 Phase II Fulvestrant + Palbociclib Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor Recruiting USA 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 Recruiting USA 0
NCT04191499 Phase II Fulvestrant + Palbociclib Fulvestrant + GDC-0077 + Palbociclib A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer Recruiting USA | CAN 23
NCT03531645 Phase II Fulvestrant + Palbociclib Fulvestrant Plus Palbociclib in Women With Advanced Low Grade Serous Carcinoma Recruiting USA 0


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