Trial Title:
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
NCT ID:
NCT06465368
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Conditions: Keywords:
human epidermal growth factor receptor 2 (HER2)
hormone receptor (HR)
HER2-negative
HR-Positive
Breast Cancer (BC)
Neoadjuvant
Postmenopausal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PF-07220060
Description:
PF-07220060 given as tablet by mouth twice a day for 14 days.
Arm group label:
Arm A/Experimental/PF-07220060 plus letrozole
Intervention type:
Drug
Intervention name:
letrozole
Description:
Letrozole given as tablet by mouth once a day for 14 days
Arm group label:
Arm A/Experimental/PF-07220060 plus letrozole
Arm group label:
Arm B/Control/letrozole
Other name:
Femara
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
South Texas Accelerated Research Therapeutics (START)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Hospital General Universitario de Elche
Address:
City:
Elche
Zip:
03203
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Mackay Memorial Hospital
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Chang Gung Medical Foundation-Linkou Branch
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Not yet recruiting
Start date:
July 11, 2024
Completion date:
October 24, 2025
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465368
https://pmiform.com/clinical-trial-info-request?StudyID=C4391025
