Pre-surgery hormone therapy to lower positive margins in lobular breast cancer
Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
This Phase 2 trial tests whether giving endocrine (hormone) therapy before breast-conserving surgery can reduce the chance of cancer at the edges of the removed tissue in postmenopausal people with ER+/HER2- invasive lobular breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07483307 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study gives neoadjuvant endocrine therapy (NET) to postmenopausal adults with biopsy-proven ER+/HER2- invasive lobular carcinoma who plan to undergo breast-conserving surgery. Participants receive NET prior to surgery and then proceed to excision, with the primary outcome being the presence or absence of cancer at the surgical margins on pathology. Secondary assessments include imaging and surgical outcomes to determine whether NET facilitates more complete resections and reduces the need for re-excision. Patients with advanced nodal disease, prior ipsilateral breast cancer, or contraindications to MRI are excluded.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal adults age 50 or older with biopsy-confirmed cT2–T3, N0–N1 ER+/HER2- invasive lobular carcinoma who choose and are medically fit for breast-conserving surgery.
Not a fit: Patients with prior cancer in the same breast, advanced regional (cN2/cN3) or metastatic disease, those judged to need neoadjuvant chemotherapy, or those who cannot undergo surgery or MRI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could lower the rate of positive margins and reduce the need for repeat surgeries, helping more patients preserve their breasts.
How similar studies have performed: Neoadjuvant endocrine therapy has produced tumor shrinkage and enabled breast conservation in some ER+ cancers, but responses in the lobular subtype have been less consistent and this specific application is relatively understudied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Anita SKCCSC(P Mamtani, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Anita Mamtani, MD
- Email: mamtana1@mskcc.org
- Phone: 646-888-6864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.