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NCT06127979 Clinical Trial

A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery

Breast Cancer Clinical Trial

Official title:
Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06127979
Other study ID # 23-311
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date November 2028

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact Minna Lee, MD
Phone 646-888-6898
Email leem15@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 42
Est. completion date November 2028
Est. primary completion date November 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• core needle biopsy
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
Other:
• blood draw
blood draw

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary assess the change in Ki67 The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed. baseline to at least 2 weeks of endocrine therapy
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