This phase II trial tests the effect of endocrine therapy before surgery (neoadjuvant) on surgical margins in patients with stage II-III estrogen receptor positive (ER+) HER2 negative (-) invasive lobular breast cancer (ILC). Endocrine therapy, such as anastrozole, letrozole, exemestane, and tamoxifen, lowers the amount of estrogen made by the body, or blocks the use of estrogen by the tumor cells. This may help stop the growth of tumor cells that need estrogen to grow. Patients who are ER+ commonly receive endocrine therapy after surgery, including a lumpectomy, and/or radiation therapy to prevent the tumor from coming back. A lumpectomy is a type of breast conserving surgery (BCS) which involves removing the tumor and a small amount of normal tissue from the breast. Giving endocrine therapy before undergoing a lumpectomy may reduce the chance of having tumor cells at the edges of tissue removed during surgery (positive margins) in patients with stage II-III ER+ HER2- ILC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07483307.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Anita Mamtani
Phone: 646-888-6864
PRIMARY OBJECTIVE:
I. To prospectively evaluate rates of positive surgical margins after initial BCS among postmenopausal women with cT2-3 N0-1 ER+/HER2- ILC who have undergone a course of neoadjuvant endocrine therapy (NET).
SECONDARY OBJECTIVES:
I. To evaluate the proportion of re-excision and/or completion mastectomy after initial BCS.
II. To determine how often a change in radiographic breast density is identified after receipt of NET.
OUTLINE:
Patients receive NET with anastrozole, letrozole, exemestane, or tamoxifen per treating medical oncologist for up to 3 months in the absence of disease progression or unacceptable toxicity. After 3 months, patients with progressive disease undergo lumpectomy or mastectomy per discretion of treatment team following standard practice. Patients with stable disease or response to therapy, continue to receive NET for up to an additional 3 months before undergoing standard lumpectomy and appropriate axillary surgery. Additionally, patients undergo mammography and magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up 2-3 weeks after BCS.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAnita Mamtani
