A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Ipatasertib; Paclitaxel; Placebo
Intervention description: Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.; Participants received paclitaxel 80 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.; Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.
Intervention MeSH terms: Paclitaxel; Ipatasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, double-blind study will estimate the efficacy, safety and
      tolerability of ipatasertib combined with paclitaxel compared with placebo combined with
      paclitaxel in participants with inoperable locally advanced or metastatic triple-negative
      breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and
      in participants with phosphatase and tensin homolog (PTEN)-low tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented triple-negative adenocarcinoma of the breast that is
             inoperable locally advanced or metastatic and is not amenable to resection with
             curative intent

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor
             specimen, required prior to randomization

          -  Measurable disease, according to the RECIST v1.1

          -  Adequate hematologic and organ function within 14 days before the first study
             treatment

          -  For female participants of childbearing potential, agreement (by both participant and
             partner) to use an effective form of contraception for the duration of the study and
             for 6 months after last dose of study treatment

        Exclusion Criteria:

          -  Any previous therapy, including chemotherapy or hormonal or targeted therapy, for
             inoperable locally advanced or metastatic triple-negative adenocarcinoma of the
             breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy
             and/or radiation treatment for locally advanced triple negative adenocarcinoma,
             provided all treatments were completed greater than or equal to (>/=) 6 months prior
             to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with
             curative intent

          -  Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1

          -  Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor
             (ER) positive, or progesterone receptor (PR) positive breast cancer

          -  Previous therapy with Akt, PI3K, and/or mTOR inhibitors

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
             prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during
             the course of the study

          -  Known presence of the brain or spinal cord metastasis, as determined by computed
             tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or
             prior radiographic assessments