A clinical trial of ipatasertib in combination with paclitaxel versus placebo and paclitaxel in patients with specific tumor alteration, Locally Advanced or Metastatic, Triple Negative Breast cancer or Hormone Receptor â?? Positive, HER2 â?? 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 â?? Positive, HER2 â?? Negative Breast Cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019047

Enrollment

450

Registered

2019-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Ipatasertib: Ipatasertib 400mg Oral QD (Day 1 to 21 of each 28 day cycle) Control Intervention1: Paclitaxel: Paclitaxel 80mg/m2

IV infusion on days 1, 8 and 15 of each 28 day cycle

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Investigator-assessed PFSTimepoint: 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

Measure	Time frame
OS, ORR, DoR, CBR, patient-reported pain (cohort B only) and HRQoLTimepoint: ORR-CR or PR on two consecutive occasions more than or equal to 4 weeks apart, as determined locally by the investigator	—

Countries

Australia, Belgium, Brazil, Canada, Chile, China, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Peru, Poland, Republic of Korea, Russian Federation, Singapore, Slovenia, Spain, Taiwan, Ukraine, United Kingdom, United States of America

Contacts

Public ContactJitendra Soni

Roche Products (India) Pvt. Ltd.

sandeep.bhatia@roche.com022-33941414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026