NCT07483307PHASE2Recruiting
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
Memorial Sloan Kettering Cancer Center
Start Date
3/13/2026
Completion Date
3/13/2030
Summary
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).
Eligibility Criteria
Age Range: 50 years to No maximum
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.
Interventions
DRUG
Neoadjuvant endocrine therapy
Conditions
Breast CancerHER2-negative Breast CancerHER2 Negative Breast CarcinomaER+ Breast CancerLobular Breast Carcinoma
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