A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause

Launched by PFIZER · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a new study medicine called PF-07220060 when taken together with letrozole, compared to letrozole alone, for treating postmenopausal women with breast cancer. The trial aims to see if the combination of these two medicines can help improve treatment outcomes for women whose breast cancer is hormone receptor-positive and HER2-negative. Participants will be randomly assigned to receive either the combination treatment or letrozole alone, and the study will last for about 14 days, followed by a follow-up visit.

To be eligible for this trial, women must be at least 18 years old, postmenopausal, and have not received any prior treatment for their breast cancer. They should have hormone receptor-positive, HER2-negative breast cancer, confirmed by tests, and must be willing to undergo a biopsy (a procedure to take a sample of tissue) on the 14th day of treatment. Throughout the study, participants will also have regular check-ups and blood tests to monitor their health. This study is currently recruiting participants and aims to provide important information about the potential benefits of combining these treatments for breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment)
• • Documented by estrogen receptor (ER) and/or progesterone receptor (PR)-positive disease by IHC or ISH
• • Participants must have Ki-67 score \>/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC
• • Participants must be willing and able to undergo a baseline and Day 14 biopsy and must have an ECOG PS or 0 or 1.
• • Participants must be treatment naive for the treatment of BC and cannot have had prior treatment with any systemic therapy (e.g., chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents or use of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken.
• Exclusion Criteria:
• • No prior systemic therapy, radiation, surgery, investigational therapy for treatment of breast cancer
• • Certain medical conditions in the previous 6 months, for example: myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism or other clinically significant episode of thromboembolism
• • Lab abnormalities outside protocol specified parameters