A Study of Ipatasertib Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Breast cancer

• Registration Number: JPRN-jRCT2080224945
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-13
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic.
-For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs.
-For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm.
-Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer
-At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
-Phase III only: Tumor specimen from the most recently collected, available tumor tissue..

Exclusion Criteria

-Pregnant or breastfeeding, or intending to become pregnant.
-Prior treatment with fulvestrant or other selective estrogen receptor down-regulator.
-Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor.
-Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer.
-Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer.
-History of Type I or Type II diabetes mellitus requiring insulin.
-History of or active inflammatory bowel disease or active bowel inflammation.
-Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections.

Study & Design

• Study Type: Interventional
• Study Design: Not specified