Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer
Breast Cancer, Invasive Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring aromatase inhibitor, breast cancer, estrogen receptor, progesterone receptor, endocrine-targeted therapy, Anti-estrogen therapy, HR+, HER2-negative, Neoadjuvant Treatment
Eligibility Criteria
Inclusion Criteria:
- Female; age ≥18 years.
- Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
- Clinically lymph node negative, confirmed by clinical exam and/or ultrasound imaging.
- Estrogen- and/or progesterone-receptor-positive tumor, defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- HER2/neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Pretreatment evaluations (minimum diagnostic workup) within 28 days prior to study
- Qualify for anti-endocrine treatment (per medical oncologist).
- Informed consent provided.
- If history of contralateral breast cancer, patient completed all treatment two years prior
- No treatment for this breast cancer or any malignancy within two years (except non-melanomatous skin cancer, carcinoma in situ of the cervix and contralateral breast cancer)
- Using adequate methods of contraception; negative pregnancy test.
- No strong CYP2D6 inhibitors.
Adequate organ function with baseline lab values.
- Absolute neutrophil count (ANC) ≥ 1500/µL.
- Hemoglobin (Hb) ≥ 9g/dL.
- Platelet count ≥ 100,000/µL.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).
- Serum bilirubin within ≤ 1.5 x ULN.
Exclusion Criteria:
- American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.
- Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
- Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- Men with breast cancer.
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- Pregnant or lactating women.
Sites / Locations
- Froedtert Hospital
Arms of the Study
Arm 1
Experimental
Neoadjuvant endocrine therapy treatment (physician's choice)
Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. 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. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.