Status and phase
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Study type
Funder types
Identifiers
About
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
Full description
Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
Evidence of clinically and/or radiologically documented disease
≥ 18 years of age
ECOG performance status of 0 or 1
No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy
Adequate hematology and organ function, in the absence of growth factors
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups, including a placebo group
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Central trial contact
Wendy Parulekar
Data sourced from clinicaltrials.gov
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