Recruiting

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

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).

ClinicalTrials.gov IDNCT07483307

PhasePHASE2

Enrollment176

SponsorMemorial Sloan Kettering Cancer Center

Age50 Years and older

SexFEMALE

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Drug: Neoadjuvant endocrine therapy — The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.

Primary outcomes

Rate of positive surgical margins after breast cancer surgery (up to 3 months)

Eligibility information

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 locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York 10065 United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York 11553 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-09.