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 (CO40016)
Johns Hopkins Kimmel Cancer Center in Baltimore
This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.
Inclusion Criteria:•Women or men aged equal to greater than 18 years with histologically 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•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1•Adequate hematologic and organ function within 14 days prior to treatment initiation•Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1•Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis:•Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue by next-generation sequencing (NGS)
Approximately 249 patients with TNBC and 201 patients with HR+/HER2- breast cancer will be enrolled at approximately 120-150 centers worldwide. Patients will be assigned to either Cohort A (TNBC) or Cohort B (HR+/HER2- breast cancer) according to the most recent locally assessed pathologically documented receptor status in their recurrent or metastatic tumor per ASCO/CAP guidelines and randomly assigned in a 2:1 ratio to the experimental arm (ipatasertib 400 mg + paclitaxel) or control arm (placebo + paclitaxel).
03/05/2019 05:03 AM