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Advanced or Metastatic Breast Cancer Drug Combination Study
A double-blind, placebo-controlled, randomized phase III study of ipatasertib in combination with paclitaxel as a treatment for patients with PIK3CA/AKT1/PTEN-altered, locally advanced or metastatic, triple-negative breast cancer or hormone receptor– positive, HER2-negative breast cancer.
The main purpose of this study is to compare the effects of ipatasertib in combination with paclitaxel (a common type of chemotherapy) versus placebo (an inactive substance that looks like ipatasertib) plus paclitaxel to find out which is better. Ipatasertib is an experimental drug. Paclitaxel is a drug that is approved in some countries including the United States for the treatment of breast cancer; however, paclitaxel will be an investigational drug for this study. This is a multicenter study that will be conducted worldwide.
In order to participate you must meet the following criteria:
- Are 18 years of age or older, with documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.
- Are willing to provide tumor tissue for central molecular analysis.
- Have valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue by next-generation sequencing (NGS).
You will be excluded from the study if any of the following criteria apply to you:
- Have had treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation.
- Have had any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast.
- Have a history of or known presence of brain or spinal cord metastases or malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer).
This is a partial list of inclusion and exclusion criteria.