PF-07220060 + Letrozole for Breast Cancer

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment)

Participants must have Ki-67 score >/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of a new medicine called PF-07220060 when used in combination with letrozole for treating breast cancer. They are looking for women over 18 years old who

Who is the study for?

This trial is for postmenopausal women aged 18 or older with a specific type of untreated breast cancer that's HR positive and HER2 negative. They must not have had prior systemic therapy, radiation, surgery, or certain medications recently. Participants need to be able to undergo biopsies and have an ECOG performance status of 0 or 1.

What is being tested?

The study compares the effects of PF-07220060 combined with letrozole versus letrozole alone in treating breast cancer. Women will be randomly assigned to one of these treatments; both are oral medications taken for a period of 14 days followed by assessments.

What are the potential side effects?

While specific side effects aren't listed here, participants can expect potential side effects from PF-07220060 plus letrozole similar to those common in cancer therapies such as fatigue, nausea, hormonal changes, and possible reactions at the biopsy site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a postmenopausal woman with HR-positive, HER2-negative breast cancer.

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My breast cancer has a Ki-67 score of 10% or higher and is in stages T1c to T4c, N0 to N2, M0.

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I haven't received any treatment for breast cancer before, including surgery, radiation, or medication.

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My cancer is positive for estrogen or progesterone receptors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy for reporting.