Recruiting

Endocrine Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06127979

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

core needle biopsy

blood draw

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06127979

Start date

Aug 30, 2024

Status verified date

May, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Breast Cancer

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. However, if a patient is receiving a clinically indicated, standard of care biopsy after enrolling on this trial, the necessary research samples may be collected during this procedure to avoid an additional research-specific procedure.

Interventions

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

blood draw

blood draw

Primary outcome measure

  • assess the change in Ki67 [ Time Frame: baseline to at least 2 weeks of endocrine therapy ]

Central Contacts and Locations

Central contacts

Minna Lee, MD

646-888-6898leem15@mskcc.org

Komal Jhaveri, MD

646-888-5157

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Minna Lee, MD

646-888-6898

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Ki67 Expression
  • BRCA2 mutation
  • ER+/HER2-
  • endocrine therapy
  • 23-311

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-02.