Study of PF-07220060 and Letrozole for Adults with HR-positive HER2-negative Advanced Breast Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT06760637
This clinical trial is testing a new treatment combination of PF-07220060 and letrozole for adults with advanced or metastatic breast cancer that is HR-positive and HER2-negative. The study compares this new combination to existing treatments to see which is more effective and safe.
Patient Parameters
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Program Overview
The aim of this study is to find out if a new treatment combination of PF-07220060 and letrozole is safe and effective for people with advanced or metastatic breast cancer that is HR-positive and HER2-negative. These types of breast cancer cells need hormones like estrogen or progesterone to grow and have little to no HER2 protein on their surface. Participants in the study have not received any previous treatment for their advanced cancer. Half of the participants will receive the new treatment combination, while the other half will receive a standard treatment chosen by the study doctor, along with letrozole. The study team will regularly check on participants to see how they are responding to the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of breast cancer that has spread to nearby tissues or other parts of the body and cannot be treated with surgery or radiation to cure it.
- Have a tumor that is positive for estrogen or progesterone receptors.
- Have a tumor that is negative for the HER2 protein.
- Have not received any previous systemic treatment for their advanced or metastatic cancer.
- Have measurable cancer or bone-only disease as defined by specific medical criteria.
Exclusion Criteria
- Are in a medical crisis due to cancer that could lead to life-threatening complications soon.
- Have current or past cancer spread to the brain or spinal cord.
- Have had a return of cancer during or within 12 months after completing previous hormone therapy.
- Have had a return of cancer during or within 12 months after completing previous CDK4/6 inhibitor therapy.
- Have poor kidney function, liver problems, or blood-related issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Summit Cancer Care, PC | 31405 | Savannah | Georgia |
| Ascension Illinois - Evanston Infusion Center | 60202 | Evanston | Illinois |
| Ascension Illinois-Skokie Infusion Center | 60077 | Skokie | Illinois |
| Orchard Healthcare Research Inc. | 60077 | Skokie | Illinois |
| Mercy Medical Center - Baltimore | 21202 | Baltimore | Maryland |
| Bozeman Health Deaconess Hospital | 59715 | Bozeman | Montana |
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