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NCT Number: NCT06127979

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

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Location status: Recruiting

Location contact

Minna Lee, MD

CONTACT

646-888-6898

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Core needle biopsy

Procedure

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

Other

blood draw

Primary outcomes

  1. assess the change in Ki67

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Komal Jhaveri, MD

CONTACT

646-888-5157

Minna Lee, MD

CONTACT

[email protected]

646-888-6898

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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