One-week versus two-week accelerated breast radiation with a tumor-bed boost

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 3 trial randomly assigns women after lumpectomy for early breast cancer to one of two post‑operative radiation schedules: 26 Gy in 5 fractions delivered over one week or 32 Gy in 10 fractions over two weeks with a concomitant tumor‑bed boost to 36 Gy (if the surgical cavity is visible). The trial tracks acute side effects, long‑term fibrosis, cosmetic outcomes, and local cancer control at 2, 5, and 10 years. Eligibility includes women with negative margins after segmental mastectomy and clinically node‑negative or limited node disease, excluding those with prior ipsilateral breast radiation or certain systemic conditions. Treatments are delivered at participating centers in New York, and imaging and clinical exams are used to monitor toxicity and tumor control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women status post segmental mastectomy.
2. If unilateral, pT1-2 breast cancer excised with negative margins.
3. If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
4. Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
5. Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
6. Women with previous contralateral treated breast cancer can be enrolled in the trial.

Exclusion Criteria:

1. Previous radiation therapy to the ipsilateral breast.
2. \>90 days from last surgery, unless s/p adjuvant chemotherapy.
3. \>60 days from last chemotherapy.
4. Male breast cancer.
5. Ongoing treatment for severe autoimmune disease.

Where it's running

• Brooklyn Methodist Hospital
  New York, New York, United States Recruiting
• New York Presbyterian Hospital
  New York, New York, United States Recruiting
• New York-Presbyterian Weill Cornell Medical College
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Silvia C. Formenti, MD — Weill Medical College of Cornell University
• Study coordinator: Fabiana Gregucci, MD
• Email: fgr4002@med.cornell.edu
• Phone: 6469623110

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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.