RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-11-06
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06127979

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-
  2. * Scheduled to undergo upfront surgery
  3. * Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines
  1. * History of breast cancer
  2. * Receipt of ET for risk reduction in the previous 3 months
  3. * Stage IV disease at presentation
  4. * Scheduled to undergo neoadjuvant systemic chemotherapy
  5. * Pregnant

Contacts and Locations

Study Contact

Minna Lee, MD
CONTACT
646-888-6898
leem15@mskcc.org
Komal Jhaveri, MD
CONTACT
646-888-5157

Principal Investigator

Minna Lee, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Minna Lee, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-06
Study Completion Date2028-11

Study Record Updates

Study Start Date2023-11-06
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer