Therapy Detail

Therapy Name Fulvestrant + Palbociclib
Synonym
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fulvestrant Faslodex ICI 182,780 Hormone - Anti-estrogens 16 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 (NCI Drug Dictionary). Faslodex (fulvestrant) is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov).
Palbociclib Ibrance PD0332991 CDK4/6 Inhibitor 8 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RB1 E268* RB1 I101fs RB1 T738_R775del RB1 V654fs 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
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
Clinical Trial Phase Therapies Title Recruitment Status
NCT02738866 Phase II Fulvestrant + Palbociclib Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor Recruiting
NCT03531645 Phase II Fulvestrant + Palbociclib Fulvestrant Plus Palbociclib in Women With Advanced Low Grade Serous Carcinoma Not yet recruiting
NCT03007979 Phase II Goserelin Fulvestrant + Palbociclib Letrozole + Palbociclib Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer Recruiting
NCT02760030 Phase II Fulvestrant + Palbociclib Fulvestrant and Palbociclib in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery Recruiting
NCT03147287 Phase II Palbociclib Fulvestrant + Palbociclib Avelumab + Fulvestrant + Palbociclib Fulvestrant Palbociclib After CDK and Endocrine Therapy (PACE) Recruiting
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
NCT02599714 Phase Ib/II Fulvestrant + Palbociclib Vistusertib Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (PASTOR) Active, not recruiting
NCT02384239 Phase II Fulvestrant + Palbociclib Palbociclib + Tamoxifen A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer Active, not recruiting