A Study of Ipatasertib in Combination with Paclitaxel as aTreatment for Participants With PIK3CA/AKT1/PTEN-Altered, locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223714

Enrollment

450

Registered

2017-11-14

Start date

2018-01-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

investigational material(s) Generic name etc : ipatasertib INN of investigational material : ipatasertib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Adequate hematologic and organ function - 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 - HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: *Patient has recurrent disease <=5 years of being on adjuvant endocrine therapy *If patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy - Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 - Valid results from either central testing or local testing confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue or blood

Exclusion criteria

Exclusion criteria: - Active infection requiring antibiotics - Known HIV infection - Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis - History of or known presence of brain or spinal cord metastases - Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast - History of Type I or Type II diabetes mellitus requiring insulin - Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia - History of or active inflammatory bowel disease - Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)

Design outcomes

Primary

Measure	Time frame
efficacy Progression-Free Survival(PFS)	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Objective Response Rate(ORR), Duration of Response(DOR), Clinical Benefit Rate(CBR), Overall Survival(OS), QOL, Adverse Events(AEs), Plasma Concentration of Ipatasertib and Its Metabolite(G-037720)	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026