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

Recruiting now · Phase 2

Conditions studied: Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer, Lobular Breast Carcinoma

In brief

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).

Key facts

Study ID

NCT07483307

Run by

Memorial Sloan Kettering Cancer Center

People needed

176

Starts

2026-03-13

Expected to finish

2030-03-13

Last updated by the study team

2026-06-04

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.
• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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