Study on PF-07220060 and Letrozole Combination for Postmenopausal Women with Breast Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT06465368
This clinical trial is exploring the effects of a new medicine, PF-07220060, when used together with letrozole, compared to letrozole alone, in treating postmenopausal women with a specific type of breast cancer.
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Program Overview
The aim of this study is to understand how well the combination of PF-07220060 and letrozole works compared to letrozole alone in treating breast cancer in postmenopausal women. Participants will be randomly assigned to receive either the combination treatment or letrozole alone. Both medications are taken orally, with PF-07220060 taken twice daily and letrozole once daily for 14 days. The study includes a screening period, treatment phase, and follow-up visit. Participants will also undergo a biopsy on Day 14 to examine the effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Women who are postmenopausal, either naturally or through surgery.
- Diagnosed with hormone receptor-positive, HER2-negative breast cancer.
- Have a Ki-67 score of 10% or higher with specific types of invasive breast cancer.
- Willing to undergo a biopsy at the start and on Day 14 of the study.
- Have not received any prior treatment for breast cancer, including chemotherapy, hormonal therapy, radiation, or surgery.
- Not using hormone replacement therapy or estrogen-containing medications within two weeks before the study.
Exclusion Criteria
- No previous treatments for breast cancer, including systemic therapy, radiation, or surgery.
- No serious medical conditions in the past six months, such as heart attack, severe heart issues, stroke, or significant blood clots.
- No lab test results outside the specified safe range for the study.
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