This phase Ib/III trial is examining the effectiveness and safety of using a novel targeted therapy (Ipatasertib) in combination with another targeted therapy (Palbociclib) and chemotherapy (Fulvestrant) to treat advanced unresectable or metastatic breast cancer.
This trial is treating patients with locally advanced inoperable or metastatic breast cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
- Your cancer has not spread to other parts of the body.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
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A phase Ib/III 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
This trial will consist of two parts: a phase Ib section and a phase III section. Eligible patients in the phase Ib section will receive single oral daily doses of Ipatasertib for a run-in period of 5-7 days, and then for Day 1-21 of the first 28-day cycle. Doses will increase to twice per day for Day 1-21 in the second cycle. Palbociclib and Fulvestrant will also be received during the phase Ib part, as per the details below.
During the phase III part eligible patients will receive either Ipatasertib or a placebo to be orally administered once per day on Days 1-21 of each 28 day cycle, at the dose identified in the part Ib phase. Patients will also receive Palbociclib to be orally administered once per day on Days 1-21 of each 28-day cycle and injections of Fulvestrant on Day 1 and 15 of the first cycle and Day 1 for all other cycles.
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