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Trial Title:
A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery
NCT ID:
NCT06127979
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Ki67 Expression
BRCA2 mutation
ER+/HER2-
endocrine therapy
23-311
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
core needle biopsy
Description:
Pre-Endocrine Therapy core needle biopsy. The pre-treatment research biopsy will require
a biopsy marker clip to document that the cancer lesion was biopsied
Arm group label:
Breast Cancer
Intervention type:
Other
Intervention name:
blood draw
Description:
blood draw
Arm group label:
Breast Cancer
Summary:
The researchers are doing this study to look at changes in Ki67 expression after at least
2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer
removal surgery. Participants will receive the endocrine therapy before their surgery.
The researchers will look at how changes in Ki67 expression compare between participants
who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2
mutation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast
cancer that is ER+/HER2-
- Scheduled to undergo upfront surgery
- Eligible for genetic testing in accordance with National Comprehensive Cancer
Network guidelines
Exclusion Criteria:
- History of breast cancer
- Receipt of ET for risk reduction in the previous 3 months
- Stage IV disease at presentation
- Scheduled to undergo neoadjuvant systemic chemotherapy
- Pregnant
Gender:
Female
Gender based:
Yes
Gender description:
Breast Cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Minna Lee, MD
Phone:
646-888-6898
Start date:
November 6, 2023
Completion date:
November 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127979
http://www.mskcc.org/mskcc/html/44.cfm
