Actively Recruiting
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
Led by Medical College of Wisconsin · Updated on 2025-10-14
100
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
CONDITIONS
Official Title
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Unilateral breast mammogram and ultrasound within 60 days before enrollment
- Diagnosed with invasive breast cancer, clinical stage I or II
- Clinically lymph node negative by exam and/or ultrasound
- Estrogen and/or progesterone receptor positive tumor with at least 1% staining cells
- HER2-negative tumor by immunohistochemistry or fluorescence in situ hybridization
- Eastern Cooperative Oncology Group performance status 0 to 2
- Bilateral or multifocal breast cancer allowed
- No distant metastases based on history, physical exam, and breast exam within 28 days prior to study entry
- Eligible for endocrine treatment as determined by medical oncologist
- Provided informed consent for study participation
- Previous breast cancer treatment completed more than two years ago
- No prior treatment for this breast cancer or any malignancy within two years except certain skin or cervical cancers
- Women of childbearing potential must use adequate contraception
- Avoid use of strong CYP2D6 inhibitors if taking tamoxifen
You will not qualify if you...
- Breast cancer stage AJCC clinical T4, N1-3, or M1
- Presence of non-breast cancers except certain skin or cervical cancers
- Purely noninvasive breast cancer (ductal or lobular carcinoma in situ)
- Male breast cancer patients
- Medical or psychiatric conditions preventing treatment or informed consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here