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RecruitingLast updated: 25 February 2025

The purpose of this study is to learn about the effects of a medicine called PF-07220060 plus hormone therapy (letrozole), compared with the effects of taking letrozole alone, for the treatment of hormone receptor-positive, HER2-negative breast cancerAN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING

Clinical summary

Summary

Eligible participants will be randomly assigned to receive the experimental treatment (PF-07220060 plus letrozole) or letrozole alone. Both PF-07220060 and letrozole are taken by mouth. PF-07220060 will be taken twice a day for 14 days, and letrozole will be taken once a day for 14 days.

Participants will have a screening period for up to 28 days. If deemed fit, they will receive study treatment for 14 days, and will then have a follow-up visit about 28 days after their last dose.

All participants will have at least one biopsy during the study. Biopsy is the removal of cells or tissues for examining. All participants will have a biopsy on Day 14. Additional assessments for safety including blood draws and interviews done by the site staff will be compelted during the study.

Conditions

This trial is treating patients with hormone receptor-positive (ER+ and/or PR+) and HER2-negative breast cancer who have not had prior treatment

Cancer

Breast Cancers Breast

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Pfizer

Scientific Title

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING

Eligibility

Inclusion

 

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

There may be additional criteria to what is listed here, speak to your doctor to confirm whether this trial is right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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