A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant endocrine therapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
Overview
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).
Interventions
- Drug Neoadjuvant endocrine therapy
The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.
Primary outcome measures
- Rate of positive surgical margins after breast cancer surgery [Time frame: up to 3 months]
Eligibility 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:
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale
Identifiers
NCT: NCT07483307 · 26-095