RecruitingBreast Cancer
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
Sponsor: Medical College of Wisconsin
You may qualify if…
- ✓ 1. Unilateral diagnostic breast mammogram and ultrasound within 60 days of enrollment.
- ✓ 2. Pathologically proven diagnosis of invasive breast cancer, clinical stage I or II.
- ✓ 3. Patients must be clinically lymph node negative. Lymph node negativity must be confirmed by clinical exam and/or ultrasound imaging.
- ✓ 4. The patient must be female.
- ✓ 5. Age ≥18 years.
- ✓ 6. Estrogen and/or progesterone receptor positive tumor defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology/College of American Pathologists guidelines.
- ✓ 7. Human epidermal growth factor receptor 2 (HER2) /neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).
- ✓ 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
You may not qualify if…
- ✕ 1. American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.
- ✕ 2. Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
- ✕ 3. Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- ✕ 4. Men with breast cancer. Male breast cancer is a rare event and it is unclear if neoadjuvant endocrine treatment approach is safe in men.
- ✕ 5. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- ✕ 6. Pregnant or lactating women are ineligible.
Where it's recruiting
Wisconsin
Milwaukee
Source: ClinicalTrials.gov · NCT06361940 · last updated 2025-10-14