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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06127979

Collaborator

(none)

Enrollment

Location

Arm

59.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: core needle biopsy Other: blood draw	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Nov 6, 2023

Anticipated Primary Completion Date :

Nov 1, 2028

Anticipated Study Completion Date :

Nov 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breast Cancer All study patients will receive standard ET for at least 2 weeks, 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.	Procedure: 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 Other: blood draw blood draw

Arm

Intervention/Treatment

Experimental: Breast Cancer

All study patients will receive standard ET for at least 2 weeks, 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.

Procedure: 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

Other: blood draw

blood draw

Outcome Measures

Primary Outcome Measures

assess the change in Ki67 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Minna Lee, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT06127979

Other Study ID Numbers:

23-311

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Memorial Sloan Kettering Cancer Center

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 13, 2023