About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Neoadjuvant endocrine therapy

Treatment groups

176 Participants
are divided into 1 treatment group

Locations

7
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725, CommackNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor