Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465368
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-13
Brief Title:
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None