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RecruitingPhase 2

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

Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests hormone therapy given before surgery for invasive lobular breast cancer, a cancer that starts in the milk-making glands. It looks at whether this treatment lowers the chance of cancer cells being left at the edges of the removed tissue. It is for women age 50 or older who have gone through menopause and plan to have surgery that keeps most of the breast.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal representative must give written consent to join.
  • You must be a woman age 50 or older who has gone through menopause.
  • A tissue sample must confirm invasive lobular breast cancer, with a tumor stage of cT2–T3 and lymph node stage of N0–N1.
  • You must choose and be healthy enough for surgery that removes the cancer but keeps most of the breast.
  • The tumor must be estrogen receptor-positive (ER+): at least 10% of cancer cells test positive for a protein that lets them respond to estrogen.
  • The tumor must be HER2-negative: testing must show no excess HER2 protein or extra copies of the HER2 gene.

Who can't join

  • You have had cancer in the same breast before.
  • The cancer has spread to more nearby lymph nodes (cN2 or cN3) or to distant parts of the body (stage 4).
  • Your cancer doctor believes you would benefit from chemotherapy before surgery.
  • You cannot have surgery to remove the breast cancer.
  • You are allergic to gadolinium, a contrast dye needed for the breast MRI scan.

Simplified for readability. The official criteria below are what the study team uses.

Official 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: 1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei. 2. 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.

Study sites (7)

NJ

NY