A randomized Phase I/II trial of fulvestrant and abemaciclib in combination with copanlisib (FAC) versus fulvestrant and abemaciclib alone (FA) for endocrine-resistant hormone receptor positive HER2 negative metastatic breast cancer (FAC vs FA)

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Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Endocrine-resistant,hormone Receptor Positive, Her2 Negative Metastatic Breast Cancer
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1) Men and women must have histologically or cytologically confirmed ER and/or PR positive, HER2 negative or non-amplified breast cancer that is stage IV, with measurable or non-measurable disease. 2) All patients must agree to provide archival tumor material for research and must agree to undergo research tumor biopsy before treatment if presence of easily accessible lesions (judged by the treating physician).

1) For patients enrolling to the randomized Phase 2 portion of the study, prior treatment with a CDK4/6 inhibitor or fulvestrant, or a PI3K inhibitor in the metastatic setting is not allowed. 2) Patients who have had chemotherapy within 3 weeks or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. 3) Patients who are receiving any other investigational agents and immunosuppressive therapy is notallowed while on study. 4) Receiving anti-arrhythmic therapy (beta blockers or digoxin are permitted) and history of allergic reactions attributed to compounds of similar chemical or biologic composition to copanlisib, PI3K inhibitors, or other agents used in study.