A phase III study of IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND PACLITAXEL as a treatment for patients with breast cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2020/05/025040
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1
Informed Consent
Woman or man age 18 years and above
Inoperable locally advanced/metastatic breast cancer (LA/MBC), Histologically documented TNBC or HR+/HER2â?? adenocarcinoma and suitable for taxane monotherapy
At least 12 month disease-free interval from last chemotherapy/radiation treatment for early BC.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Life expectancy of at least 6 months
Measurable disease according to RECIST v1.1
formalin-fixed, paraffin-embedded tumor (FFPE) tissue, [PIK3CA/AKT1/PTEN-altered status and central ctDNA]
Adequate hematologic and organ function within 14 days before the first study treatment
Fasting total serum glucose <= 150 mg/dL and HbA1C <= 7.5%,
Active infection requiring systemic anti-microbial treatment, Known HIV infection, Active viral or other Hepatitis
New York Heart Association Class II, III, or IV heart failure, LVEF less than 50%
History of or known presence of brain or spinal cord metastases by CT/ MRI
Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2â?? adenocarcinoma of the breast
Uncontrolled pleural effusion, pericardial effusion, or ascites
History of or active Inflammatory bowel disease, Lung disease
Prior treatment with an AKT inhibitor (Prior PI3K or mTOR inhibitors are allowed)
No uncontrolled disease/unresolved toxicity or clinically relevant condition which may contraindicate use of an investigational drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigator-assessed progression-free survival (PFS)Timepoint: from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method â?¢To independently evaluate the efficacy of ipatasertib plus atezolizumab plus paclitaxel compared with control arm treatment in each cohortTimepoint: ORR-CR or <br/ ><br>PR on two consecutive occasions more than or equal to 4 weeks apart, as determined locally by the investigator