Dysautonomia International

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

Purpose

The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).

Conditions

Breast Cancer
HER2-negative Breast Cancer
HER2 Negative Breast Carcinoma
ER+ Breast Cancer

Eligibility

Eligible Ages: Over 50 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

Written informed consent by participant or legally authorized representative - Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment. - Tumors of the ER+/HER2- subtype, defined as: 1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei. 2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.

Exclusion Criteria

Patients with prior ipsilateral breast cancer. - Patients with advanced regional disease (cN2/cN3) or stage 4 disease. - Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist. - Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease). - Patients with gadolinium allergy, precluding the use of breast MRI.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Participants with ER+/HER2- Breast Cancer	Participants will be postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC, ER+/HER2- subtype	Drug: Neoadjuvant endocrine therapy The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen. Other names: NET

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920