Clinical trial NCT06465368: A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: human epidermal growth factor receptor 2 (HER2)
hormone receptor (HR)
HER2-negative
HR-Positive
Breast Cancer (BC)
Neoadjuvant
Postmenopausal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of Ki-67
timeFrame: Day 14
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Baseline, Day 14, and Day 28 post last treatment follow-up visit
measure: Incidence of Serious AEs
timeFrame: Baseline, Day 14, and Day 28 post last treatment follow-up visit
measure: Incidence of AEs leading to Discontinuation
timeFrame: Baseline, Day 14, and Day 28 post last treatment follow-up visit
measure: Ctrough and peri-biopsy plasma concentrations of PF-07220060
timeFrame: Pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy
measure: Circulating tumor DNA (ctDNA) measurements
timeFrame: Baseline and Day 14
measure: Percentage of Ki-67
timeFrame: Screening and Day 14
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
city: Livorno
country: Italy
facility: Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
state: Toscana
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Kraków
country: Poland
facility: Pratia MCM Krakow
state: Małopolskie
city: Skórzewo
country: Poland
facility: AIDPORT Sp. z o.o.
state: Wielkopolskie
city: Komarno
country: Slovakia
facility: Nemocnica AGEL Komarno
state: Nitriansky KRAJ
city: Banka
country: Slovakia
facility: Medeon, s.r.o.
state: Trnavský KRAJ
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [barcelona]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [cataluña]
city: Jerez de la Frontera
country: Spain
facility: Hospital Jerez de la Frontera
state: Cádiz
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
state: Madrid, Comunidad DE
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad DE
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Málaga
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Gävle
country: Sweden
facility: Sjukhuset I Gävle
state: Gävleborgs LÄN [se-21]
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying Branch
state: Tainan
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: