Actively Recruiting
Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-04
176
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well neoadjuvant endocrine therapy (NET) works for postmenopausal women aged 50 years and older with invasive lobular carcinoma (ILC) of the breast. The study focuses on women with the ER+/HER2- subtype who plan to have breast-conserving surgery (BCS). The main goal is to determine if NET reduces the chance of cancer cells being found at the edges of tissue removed during surgery, which is known as positive surgical margins. Participants will receive neoadjuvant endocrine therapy using drugs such as anastrozole, letrozole, exemestane, or tamoxifen before surgery. The treatment is given before the planned breast-conserving surgery. The study is a phase 2 trial and includes women with biopsy-confirmed tumors classified as stage cT2-T3 N0-1. During the study, participants will be monitored for up to 3 months to assess the rate of positive surgical margins after their breast cancer surgery. Researchers will review surgical outcomes and safety data. The study team will also evaluate how the endocrine therapy affects surgical success and patient health during this period. The total participation time includes treatment before surgery and follow-up assessments afterward to measure surgical results.
CONDITIONS
Brief Title
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent by participant or legally authorized representative
- Postmenopausal women aged 6550 years with biopsy-proven cT2-T3 N0-1 invasive lobular carcinoma
- Tumors must be ER-positive with at least 10% immunoreactive tumor nuclei
- Tumors must be HER2-negative as defined by specific assay criteria
- Must be medically fit and opt to undergo breast-conserving surgery at enrollment
You will not qualify if you...
- Prior cancer in the same breast (ipsilateral breast cancer)
- Advanced regional disease (cN2 or cN3) or stage 4 breast cancer
- Patients recommended for neoadjuvant chemotherapy by their medical oncologist
- Not candidates for definitive breast surgery due to inoperable or stage 4 disease
- Allergy to gadolinium preventing the use of breast MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months
Participants receive neoadjuvant endocrine therapy using anastrozole, letrozole, exemestane, or tamoxifen before surgery.
Duration - 1 day
Participants undergo breast-conserving surgery following neoadjuvant endocrine therapy.
1 surgery visit (in-person)
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Anita Mamtani, MD
G
George Plitas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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