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
- Conditions
- Breast cancer
- Registration Number
- JPRN-jRCT2080223714
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 450
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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Progression-Free Survival(PFS)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>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)