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NCT Number: NCT07483307

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

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).

Recruiting

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Lobular ER+ Breast Cancer HER2 Negative Breast Carcinoma HER2-negative Breast Cancer Lobular Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Neoadjuvant endocrine therapy

Drug

The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.

Other names: NET

Primary outcomes

  1. Rate of positive surgical margins after breast cancer surgery

    Time frame: up to 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anita Mamtani, MD

CONTACT

[email protected]

646-888-6864

George Plitas, MD

CONTACT

[email protected]

646-888-5368

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 19, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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