Phase II Study on Inavolisib, Ribociclib, and Fulvestrant for Advanced Breast Cancer
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT07405801
This clinical trial is testing a new combination of drugs, Inavolisib, Ribociclib, and Fulvestrant, to see if they are effective and safe for treating advanced breast cancer that is resistant to hormone therapy. The study compares this combination to a placebo with Ribociclib and Fulvestrant.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate whether a new combination of drugs—Inavolisib, Ribociclib, and Fulvestrant—can effectively treat advanced breast cancer that does not respond to hormone therapy. The study will compare this combination to a placebo with Ribociclib and Fulvestrant to see which is more effective and safe for patients with hormone receptor-positive, HER2-negative advanced breast cancer.
Eligibility Criteria
Inclusion Criteria
- Men or women with advanced breast cancer that cannot be treated with surgery or radiation.
- Cancer must be hormone receptor-positive, meaning it grows in response to hormones like estrogen or progesterone.
- Participants should not have received any previous treatment for advanced breast cancer and must have experienced cancer progression during or shortly after hormone therapy.
- Must have specific genetic markers confirmed by lab tests, including no PIK3CA mutation and a specific chromosome loss.
- Must have measurable cancer according to standard criteria.
Exclusion Criteria
- Have a type of breast cancer called metaplastic breast cancer.
- Have had radiation therapy within two weeks before joining the study.
- Need chemotherapy according to treatment guidelines due to severe symptoms.
- Have Type 2 diabetes requiring ongoing treatment or any history of Type 1 diabetes.
- Have untreated or active cancer spread to the brain or spinal cord, unless previously treated and stable.
- Have a history of specific types of cancer spread to the brain or spinal cord.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Avera Cancer Institute - Marshall | 56258 | Marshall | Minnesota |
| Avera Cancer Institute - Aberdeen | 57401 | Aberdeen | South Dakota |
| Avera Cancer Institute - Mitchell | 57301 | Mitchell | South Dakota |
| Avera Cancer Institute - Pierre, SD | 57501 | Pierre | South Dakota |
| Avera Cancer Institute | 57105 | Sioux Falls | South Dakota |
| AMG Oncology and Hematology Avera Cancer Institute - Yankton | 57078 | Yankton | South Dakota |
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