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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465368
• Other study ID #: C4391025
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2, 2024
• Est. completion date: October 15, 2025

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about the effects of the study medicine PF-07220060 plus letrozole, compared with the effects of taking letrozole alone without PF-07220060 for treatment of breast cancer.

This study is seeking for participants who are:

• women of age 18 years and older post menopause (either naturally or surgically).

• confirmed to have Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) negative breast cancer. HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface.

• not been treated for their cancer before this study.

Participants will be randomly assigned (like flipping a coin) to receive the 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. 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 then will 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 completed during the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• PF-07220060
PF-07220060 given as tablet by mouth twice a day for 14 days.
• letrozole
Letrozole given as tablet by mouth once a day for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Ki-67	Centrally assessed biopsy	Day 14
Secondary	Incidence of Adverse Events (AEs)		Baseline, Day 14, and Day 28 post last treatment follow-up visit
Secondary	Incidence of Serious AEs		Baseline, Day 14, and Day 28 post last treatment follow-up visit
Secondary	Incidence of AEs leading to Discontinuation		Baseline, Day 14, and Day 28 post last treatment follow-up visit
Secondary	Ctrough and peri-biopsy plasma concentrations of PF-07220060	Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.	Pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy
Secondary	Circulating tumor DNA (ctDNA) measurements	Evaluate response on treatment	Baseline and Day 14
Secondary	Percentage of Ki-67	All participants will have Ki-67 staining from the biopsy sample on Day 14 and Screening if not previously available	Screening and Day 14

External Links

•   To obtain contact information for a study center near you, click here.