Study on Capivasertib and Fulvestrant vs Placebo and Fulvestrant for Treating Advanced HR+/HER2- Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04305496
This clinical trial is testing whether a combination of the drugs capivasertib and fulvestrant is more effective than fulvestrant alone in treating patients with advanced HR+/HER2- breast cancer that cannot be surgically removed or has spread to other parts of the body.
Patient Parameters
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Program Overview
The purpose of this study is to compare the effectiveness of a new drug combination, capivasertib and fulvestrant, against a placebo and fulvestrant in patients with advanced hormone receptor-positive, HER2-negative breast cancer. This study focuses on patients whose cancer has returned or progressed after treatment with aromatase inhibitors.
Description
This Phase III study is designed to evaluate the effectiveness of combining capivasertib with fulvestrant compared to a placebo with fulvestrant in patients with advanced HR+/HER2- breast cancer. The study is double-blind, meaning neither the patients nor the researchers know who is receiving the actual drug combination or the placebo. The trial is randomized, ensuring that patients are randomly assigned to either the treatment or placebo group. The focus is on patients whose cancer has returned or progressed after previous treatment with aromatase inhibitors.
Eligibility Criteria
Inclusion Criteria
- Adult women (pre- and post-menopausal) and men with advanced HR+/HER2- breast cancer.
- Women who are pre-menopausal must be willing to take an LHRH agonist during the study.
- Cancer must have progressed or returned after treatment with aromatase inhibitors.
- Must have measurable cancer that can be tracked using scans.
- Must provide a tumor sample for testing.
- Must be in good overall health with a performance status score of 0 or 1.
Exclusion Criteria
- Have severe symptoms or disease that makes endocrine therapy unsuitable.
- Have had more than two lines of hormone therapy or more than one line of chemotherapy for advanced cancer.
- Have previously been treated with certain cancer drugs like AKT, PI3K, or mTOR inhibitors.
- Have unresolved side effects from previous treatments.
- Have certain heart conditions or abnormal heart rhythms.
- Have uncontrolled diabetes or blood sugar issues.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85234 | Gilbert | Arizona |
| Research Site | 92868 | Orange | California |
| Research Site | 94143 | San Francisco | California |
| Research Site | 90603 | Whittier | California |
| Research Site | 33905 | Fort Myers | Florida |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 66205 | Westwood | Kansas |
| Research Site | 21201 | Baltimore | Maryland |
| Research Site | 02111-1520 | Boston | Massachusetts |
| Research Site | 55905 | Rochester | Minnesota |
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