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

This study is for postmenopausal women aged 18 or older with stage I-III invasive breast cancer that is ER+/HER2- (estrogen receptor-positive/human epidermal growth factor receptor 2-negative). The researchers want to see how a marker called Ki67 changes after you receive endocrine therapy (hormone therapy) before your breast cancer surgery. They will compare these changes between women who carry the BRCA2 gene mutation and those who do not. To join, you must be scheduled for upfront surgery and be eligible for genetic testing if you are in the BRCA2 arm of the study. The study aims to assess the change in Ki67 expression from the start of endocrine therapy to at least two weeks into treatment.

Study design
This is an interventional study with a planned enrollment of 42 participants. It is not specified if it is randomized or blinded.
What's involved
You would have a core needle biopsy before starting endocrine therapy, which will include placing a biopsy marker clip. You will also have a blood draw.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint assesses changes in Ki67 from baseline to at least 2 weeks of endocrine therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06127979

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

Recruiting
NAAges 18+Interventional
Memorial Sloan Kettering Cancer Center
~42 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:core needle biopsyblood draw

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
assess the change in Ki67
Measured over baseline to at least 2 weeks of endocrine therapy
Breast Cancer
1 sites across 1 states
New York1
  • Minna Lee, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • assess the change in Ki67baseline 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.