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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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

External Links

•   Memorial Sloan Kettering Cancer Center