Study on a New Medicine ARV-471 for People with Advanced Metastatic Breast Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT05654623
This clinical trial is exploring a new medicine called ARV-471 for treating advanced metastatic breast cancer. The study compares ARV-471 to an existing treatment, fulvestrant, to see which is more effective and safe.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to understand the safety and effects of a new medicine, ARV-471, compared to fulvestrant in people with advanced breast cancer. This type of cancer is challenging to treat as it may have spread to other parts of the body like bones, lungs, or liver. Fulvestrant is already used for breast cancer treatment, while ARV-471 is a new option being tested.
Description
This study is for people with advanced breast cancer that has returned or spread and cannot be fully treated with surgery or radiation. Participants should have cancer that responds to hormone therapy and have previously received a specific type of treatment called CDK4/6 inhibitor therapy along with hormone therapy. Participants will be divided into two groups: one will receive the new medicine ARV-471, and the other will receive fulvestrant. ARV-471 is taken by mouth once a day with food, while fulvestrant is given as an injection into the muscle. The study will continue until the cancer worsens or side effects become too severe. Participants will visit the study clinic every four weeks.
Eligibility Criteria
Inclusion Criteria
- Adults with breast cancer that has come back or spread and cannot be treated with surgery or radiation.
- Confirmed diagnosis of estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer.
- Have received one type of CDK4/6 inhibitor therapy with hormone therapy for advanced cancer.
- Allowed to have had one additional hormone therapy for advanced cancer.
- Cancer must have shown progression during or after the last treatment.
- Must have measurable disease or bone-only disease.
- Good overall health with an ECOG performance status of 0 or 1.
- Willing to provide blood and tumor samples for the study.
Exclusion Criteria
- Cancer has spread to vital organs and poses immediate life-threatening risks.
- Previous treatment with ARV-471, fulvestrant, or similar drugs.
- Prior chemotherapy for advanced cancer.
- Poor liver, kidney, or bone marrow function.
- Active cancer spread to the brain.
- Other significant health issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| CBCC Global Research, Inc. | 93309 | Bakersfield | California |
| Comprehensive Blood and Cancer Center | 93309 | Bakersfield | California |
| California Cancer Associates for Research and Excellence, Inc. (cCARE) | 92024 | Encinitas | California |
| California Cancer Associates for Research and Excellence | 93720 | Fresno | California |
| Providence Queen of the Valley Medical Center | 94558 | Napa | California |
| California Cancer Associates for Research and Excellence | 92069 | San Marcos | California |
| Providence Medical Foundation | 95403 | Santa Rosa | California |
| Olive View-UCLA Medical Center | 91342 | Sylmar | California |
| TMPN Cancer Care research office | 90505 | Torrance | California |
| Torrance Memorial Physician Network / Cancer Care | 90505 | Torrance | California |
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