This phase II trial tests whether endocrine therapies, anastrozole, letrozole, exemestane, or tamoxifen, work to shrink tumors before surgery (neoadjuvant) in patients with estrogen receptor positive, HER2-negative stage I-II breast cancer. Estrogen can cause the growth of breast cancer cells. Anastrozole, letrozole, exemestane, and tamoxifen lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Giving anastrozole, letrozole, exemestane, or tamoxifen before surgery may shrink the tumor and reduce the amount of normal tissue that needs to be removed.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05150652.
PRIMARY OBJECTIVE:
I. Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as estrogen receptor (ER)-positive, HER2 negative, node-negative breast carcinoma (single lesion only).
SECONDARY OBJECTIVES:
I. Residual cancer burden as defined by the MD Anderson Cancer Center’s tool.
II. Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response).
III. Medication diary review (cutoff for compliance is 80%).
IV. Satisfaction with cosmetic outcome.
EXPLORATORY OBJECTIVE:
I. Largest caliper measurement on post-therapy imaging versus (vs.) largest final size of tumor.
OUTLINE: Patients are assigned to 1 of 4 arms.
ARM I: Patients receive anastrozole orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo mammograph with or without ultrasound, and blood sample collection throughout the study.
ARM II: Patients receive letrozole PO QD on days 1-28. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo mammograph with or without ultrasound, and blood sample collection throughout the study.
ARM III: Patients receive exemestane PO QD on days 1-28. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo mammograph with or without ultrasound, and blood sample collection throughout the study.
ARM IV: Patients receive tamoxifen PO QD on days 1-28. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo mammograph with or without ultrasound, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up for up to 1 year after surgery.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorIrada Ibrahim-Zada
