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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: PF-07220060; Drug: letrozole

• Registration Number: NCT06465368
• Lead Sponsor: Pfizer

Brief 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).
...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Study Start: 2024-07-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-10-24
• Study Completion: 2025-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 118

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A/Experimental/PF-07220060 plus letrozole	PF-07220060	PF-07220060 given as tablet by mouth twice a day for 14 days. Letrozole given as tablet by mouth once a day for 14 days.
Arm B/Control/letrozole	letrozole	Letrozole given by mouth once a day for 14 days.
Arm A/Experimental/PF-07220060 plus letrozole	letrozole	PF-07220060 given as tablet by mouth twice a day for 14 days. Letrozole given as tablet by mouth once a day for 14 days.

Primary Outcome Measures

Name	Time	Method
Rate of Ki-67	Day 14	Centrally assessed biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (28)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch; 🇨🇳 Taoyuan, Taiwan

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

UZ Leuven; 🇧🇪 Leuven, Vlaams-brabant, Belgium

Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno; 🇮🇹 Livorno, Toscana, Italy

Istituto Europeo di Oncologia IRCCS; 🇮🇹 Milano, Italy

Pratia MCM Krakow; 🇵🇱 Kraków, Małopolskie, Poland

AIDPORT Sp. z o.o.; 🇵🇱 Skórzewo, Wielkopolskie, Poland

Nemocnica AGEL Komarno; 🇸🇰 Komarno, Nitriansky KRAJ, Slovakia

Medeon, s.r.o.; 🇸🇰 Banka, Trnavský KRAJ, Slovakia

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Barcelona [barcelona], Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalunya [cataluña], Spain

Hospital Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Madrid, Comunidad DE, Spain

Hospital Universitario San Cecilio; 🇪🇸 Granada, Spain

Hospital Universitario HM Sanchinarro; 🇪🇸 Madrid, Spain

Sjukhuset I Gävle; 🇸🇪 Gävle, Gävleborgs LÄN [se-21], Sweden

Chi Mei Hospital - Liouying Branch; 🇨🇳 Tainan City, Tainan, Taiwan

South Texas Accelerated Research Therapeutics (START); 🇺🇸 San Antonio, Texas, United States

Seoul National University Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Madrid, Comunidad DE, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Málaga, Spain

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan