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).
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.
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.
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).
Single group
Neoadjuvant endocrine therapy
DrugThe endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.
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.
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