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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: core needle biopsy; Other: blood draw

Study type: Interventional

Funder types: Other

Identifiers

NCT06127979

23-311

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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(BRCA2 arm only)

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Breast Cancer

Experimental group

Description:

All study patients will receive standard ET for at least 2 weeks. In accordance with the standard of care, postmenopausal women will receive AI (anastrazole 1mg daily tablet, letrozole 2.5mg daily tablet, or exemestane 25mg daily tablet 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. In collaboration with the surgical team, Oncotype can be sent on this research biopsy after pathology assessment. This will enable the patient to receive the Oncotype result and to gain knowledge on the recommendation for adjuvant chemotherapy about 4-6 weeks earlier than our normal workflow.

Treatment:

Other: blood draw

Procedure: core needle biopsy