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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06465368




Registration number
NCT06465368
Ethics application status
Date submitted
13/06/2024
Date registered
18/06/2024
Date last updated
19/11/2024

Titles & IDs
Public title
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
Scientific 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
Secondary ID [1] 0 0
C4391025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-07220060
Treatment: Drugs - letrozole

Experimental: Arm A/Experimental/PF-07220060 plus 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.

Active comparator: Arm B/Control/letrozole - Letrozole given by mouth once a day for 14 days.


Treatment: Drugs: PF-07220060
PF-07220060 given as tablet by mouth twice a day for 14 days.

Treatment: Drugs: letrozole
Letrozole given as tablet by mouth once a day for 14 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Ki-67
Timepoint [1] 0 0
Day 14
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Baseline, Day 14, and Day 28 post last treatment follow-up visit
Secondary outcome [2] 0 0
Incidence of Serious AEs
Timepoint [2] 0 0
Baseline, Day 14, and Day 28 post last treatment follow-up visit
Secondary outcome [3] 0 0
Incidence of AEs leading to Discontinuation
Timepoint [3] 0 0
Baseline, Day 14, and Day 28 post last treatment follow-up visit
Secondary outcome [4] 0 0
Ctrough and peri-biopsy plasma concentrations of PF-07220060
Timepoint [4] 0 0
Pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy
Secondary outcome [5] 0 0
Circulating tumor DNA (ctDNA) measurements
Timepoint [5] 0 0
Baseline and Day 14
Secondary outcome [6] 0 0
Percentage of Ki-67
Timepoint [6] 0 0
Screening and Day 14

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/10/2025
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Belgium
State/province [2] 0 0
Vlaams-brabant
Country [3] 0 0
Italy
State/province [3] 0 0
Toscana
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul-teukbyeolsi [seoul]
Country [6] 0 0
Poland
State/province [6] 0 0
Malopolskie
Country [7] 0 0
Poland
State/province [7] 0 0
Wielkopolskie
Country [8] 0 0
Slovakia
State/province [8] 0 0
Nitriansky KRAJ
Country [9] 0 0
Slovakia
State/province [9] 0 0
Trnavský KRAJ
Country [10] 0 0
Spain
State/province [10] 0 0
Alicante
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona [barcelona]
Country [12] 0 0
Spain
State/province [12] 0 0
Catalunya [cataluña]
Country [13] 0 0
Spain
State/province [13] 0 0
Cádiz
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid, Comunidad DE
Country [15] 0 0
Spain
State/province [15] 0 0
Málaga
Country [16] 0 0
Spain
State/province [16] 0 0
Granada
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Sweden
State/province [18] 0 0
Gävleborgs LÄN [se-21]
Country [19] 0 0
Taiwan
State/province [19] 0 0
Tainan
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06465368
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06465368