Status:
TERMINATED
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be...
Eligibility Criteria
Inclusion
- 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
- Phase III only: Tumor specimen from the most recently collected, available tumor tissue
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04060862
Start Date
November 21 2019
End Date
August 29 2023
Last Update
November 8 2024
Active Locations (20)
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1
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2621
4
Dana-Farber Cancer Institute; GYN Oncology
Boston, Massachusetts, United States, 02215