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 — DRUGChoice 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 therapyOnce 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 Office866-680-0505
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Lubna N Chaudhary, MD |
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