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About
The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants treated with single-agent fulvestrant.
Full description
The drug being tested in this study is called sapanisertib. Sapanisertib is being tested to treat postmenopausal women with advanced or metastatic estrogen receptor (ER) positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer that has progressed during or after aromatase inhibitor (AI) therapy. This study will evaluate the efficacy and safety of combination of fulvestrant + daily sapanisertib and fulvestrant + weekly sapanisertib compared with fulvestrant alone.
The study will enroll approximately 153 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
All participants will receive either fulvestrant 500 mg intramuscularly (IM), fulvestrant 500 mg + sapanisertib 4 mg daily or fulvestrant 500 mg + sapanisertib 30 mg weekly.
This multicenter trial will be conducted Spain and the USA. Participants will make multiple visits to the clinic, and end of treatment (EOT) visit which will occur 30 to 40 days after receiving their last dose of study drug or before the start of any subsequent anticancer therapy. After EOT, participants will be followed for progression free survival (PFS) and overall survival (OS).
Enrollment
Sex
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Inclusion criteria
Female participants aged 18 years or older who are postmenopausal.
Histologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence.
Histological confirmation and documentation of estrogen receptor (ER)-positive status (≥1% positive stained cells).
Histological or cytological confirmation and documentation of human epidermal growth factor receptor-2 (HER2)-negative status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.
Measurable disease defined as either of the following:
Progressive Disease (PD) during prior aromatase inhibitor (AI) therapy.
Have a history of brain metastasis provided that all of the following criteria are met:
Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
141 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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