At a glance
ClinicalIndex Comparison Record- ✓Women or men aged ≥18 years with histologically documented TNBC or HR+/HER2- adenocarcinoma that is locally advanced or metastatic and not amenable to resection with curative intent
- ✓ECOG Performance Status 0 or 1
- ✓Measurable disease per RECIST v1.1
- ✓Confirmation of PIK3CA/AKT1/PTEN-altered status by validated molecular assay (central or local testing of tumor tissue or blood)
- ✕Previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- breast cancer (neo/adjuvant chemotherapy allowed if ≥12 month disease-free interval)
- ✕History of or known brain or spinal cord metastases
- ✕Prior treatment with AKT inhibitor (prior PI3K or mTOR inhibitors allowed)
- ✕Malignancies other than breast cancer within 5 years (except cervical carcinoma in situ, non-melanoma skin cancer, or Stage I uterine cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ipatasertib, Paclitaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 579 participants across 176 sites in 30 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Ipatasertib, 400 milligrams (mg), administered orally once a day (QD) on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Paclitaxel, 80 mg/square meter (m\^2), administered intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Matching placebo, administered orally QD on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.