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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: core needle biopsy; Other: blood draw

• Registration Number: NCT06127979
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-06
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast Cancer	core needle biopsy	All study patients will receive standard ET for at least 2 weeks, which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis.
Breast Cancer	blood draw	All study patients will receive standard ET for at least 2 weeks, which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis.

Primary Outcome Measures

Name	Time	Method
assess the change in Ki67	baseline to at least 2 weeks of endocrine therapy	The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States