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NCT06465368 | RECRUITING | Breast Cancer

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

Condition or disease

Breast Cancer

Intervention/treatment

PF-07220060

letrozole

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 118 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-07-11
Estimated Primary Completion Date : 2025-10-24
Estimated Study Completion Date : 2025-10-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause

Location Details

NCT06465368

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States, 78229

NOT YET RECRUITING

Australia, Victoria

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

NOT YET RECRUITING

Australia, Victoria

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3052

NOT YET RECRUITING

Belgium, Flemish Brabant

UZ Leuven

Leuven, Flemish Brabant, Belgium, 3000

NOT YET RECRUITING

Italy, Tuscany

Usl Tuscany Company Nord West Civil Hospital of Livorno

Livorno, Tuscany, Italy, 57124

NOT YET RECRUITING

Italy,

European Institute of IRCCS Oncology

Milano, Italy, 20141

NOT YET RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080

NOT YET RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722

NOT YET RECRUITING

Korea, Republic of, Seoul-teukbyeolsi [seoul]

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 05505

NOT YET RECRUITING

Poland, Lesser Poland

Winging MCM Krakow

Cracow, Lesser Poland, Poland, 30-727

NOT YET RECRUITING

Poland, Greater Poland

AIDPORT Sp. z o.o.

Skórzewo, Greater Poland, Poland, 60-185

NOT YET RECRUITING

Slovakia, Nitriansky region

Hospital Agel Komarno

Mosque, Nitra region, Slovakia, 945 05

NOT YET RECRUITING

Slovakia, Trnava Region

Medeon, s.r.o.

Knock, Trnava region, Slovakia, 921 01

NOT YET RECRUITING

Spain, Alicante

Elche University General Hospital

Elche, Alicante, Spain, 03203

NOT YET RECRUITING

Spain, Barcelona [Barcelona]

Vall d'Hebron University Hospital

Barcelona, Barcelona [Barcelona], Spain, 08035

NOT YET RECRUITING

Spain, Catalunia [callow]

Hospital of the Holy Cross and Sant Pau

Barcelona, Catalunia [callow], Spain, 08041

NOT YET RECRUITING

Spain, Cádiz

Jerez de la Frontera Hospital

Jerez de la Frontera, Cádiz, Spain, 11407

NOT YET RECRUITING

Spain, Madrid, community of

Gregorio Marañon University General Hospital

Madrid, Madrid, community of, Spain, 28009

NOT YET RECRUITING

Spain, Madrid, community of

October 12 University Hospital

Madrid, Madrid, community of, Spain, 28041

NOT YET RECRUITING

Spain, Málaga

Virgen de la Victoria University Hospital

Malaga, Málaga, Spain, 29010

NOT YET RECRUITING

Spain,

San Cecilio University Hospital

Granada, Spain, 18016

NOT YET RECRUITING

Spain,

HM Sanchinarro University Hospital

Madrid, Spain, 28050

NOT YET RECRUITING

Sweden, Gävleborgs West [s-21]

The hospital in Gävle

Gävle, Gävleborgs West [s-21], Sweden, 80187

NOT YET RECRUITING

Taiwan, Tainan

Chi Mei Hospital - Liouying Branch

Tainan City, Tainan, Taiwan, 73657

NOT YET RECRUITING

Taiwan,

National Cheng If University Hospital

Tainan, Taiwan, 704

NOT YET RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 10002

NOT YET RECRUITING

Taiwan,

Mackay Memorial Hospital

Taipei, Taiwan, 10449

NOT YET RECRUITING

Taiwan,

Chang Gung Medical Foundation-Linkou Branch

taoyuan, Taiwan, 333