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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06127979
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 30, 2024
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Minna Lee, MD
646-888-6898

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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