Pre-surgery hormone therapy to lower positive margins in lobular breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study gives neoadjuvant endocrine therapy (NET) to postmenopausal adults with biopsy-proven ER+/HER2- invasive lobular carcinoma who plan to undergo breast-conserving surgery. Participants receive NET prior to surgery and then proceed to excision, with the primary outcome being the presence or absence of cancer at the surgical margins on pathology. Secondary assessments include imaging and surgical outcomes to determine whether NET facilitates more complete resections and reduces the need for re-excision. Patients with advanced nodal disease, prior ipsilateral breast cancer, or contraindications to MRI are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Anita SKCCSC(P Mamtani, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Anita Mamtani, MD
• Email: mamtana1@mskcc.org
• Phone: 646-888-6864

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Re‑irradiating the breast after a second lumpectomy

  This trial will test whether targeted re‑irradiation (IMRT) after a second lumpectomy is safe for people with ER+ / HER2‑ breast cancer who previously received breast radiation.

  Recruiting at 2 sites Baptist Health South Florida · Boca Raton, Florida and 1 other locations · NCT06867484

• Testing Abemaciclib with Radiation Therapy for Metastatic Breast Cancer

  This study is testing different doses of the drug abemaciclib in people with metastatic breast cancer who are also getting hormone therapy and radiation to see if it helps them better manage their symptoms.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06678269

• Datopotamab deruxtecan for treating breast cancer that has spread to the brain

  This study is testing a new drug called datopotamab deruxtecan to see if it can help people with HER2-negative breast cancer that has spread to the brain.

  Recruiting at 3 sites Phase 2 Dana-Farber Cancer Institute · Miami, Florida and 2 other locations · NCT06176261

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• RGT-490 for adults with PIK3CA-mutated advanced solid tumors

  This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.

  Recruiting at 6 sites Phase 1 Regor Pharmaceuticals Inc. · Los Angeles, California and 5 other locations · NCT07524322

• Adherence to Cell Cycle Inhibitors with Endocrine Therapy in Localized High-Risk ER+ Breast Cancer

  This study checks how well patients with localized ER+ breast cancer stick to a combined endocrine therapy and CDK4/6 inhibitor after surgery.

  Recruiting University Hospital, Grenoble · Grenoble · NCT07443774

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.