A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07483307
This study evaluates neoadjuvant endocrine therapy (NET) using anastrozole, letrozole, exemestane, or tamoxifen in postmenopausal women aged ≥50 with ER+/HER2- invasive lobular carcinoma undergoing breast-conserving surgery. Eligibility requires biopsy-proven cT2-T3 N0-1 ILC. The goal is to assess NET's effectiveness in reducing positive surgical margins.
Patient Parameters
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Program 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).
Eligibility Criteria
Inclusion Criteria
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Written informed consent by participant or legally authorized representative
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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.
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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