Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06361940
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Aromatase inhibitors or tamoxifen — DRUG
    Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status.

Study Details

This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).

Key Dates

Start date
Sep 30, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard-of-care Endocrine therapy
    Once enrolled, patients would be treated with the current standard-of-care endocrine therapy.

Primary Outcome Measure

Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors. [ Time Frame: Time of surgery ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226
Lubna N Chaudhary, MD

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