A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorMemorial Sloan Kettering Cancer Center

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