A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
1 other identifier
interventional
176
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Mar 2026
Typical duration for phase_2 breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2026
CompletedFirst Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 13, 2030
June 4, 2026
June 1, 2026
4 years
March 16, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of positive surgical margins after breast cancer surgery
To prospectively evaluate rates of positive surgical margins after initial breast cancer surgery/BCS among postmenopausal women with cT2-3 N0-1 ER+/HER2- ILC who have undergone a course of NET.
up to 3 months
Study Arms (1)
Participants with ER+/HER2- Breast Cancer
EXPERIMENTALParticipants will be postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC, ER+/HER2- subtype
Interventions
The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anita SKCCSC(P Mamtani, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 19, 2026
Study Start
March 13, 2026
Primary Completion (Estimated)
March 13, 2030
Study Completion (Estimated)
March 13, 2030
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.