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Two Versus One Week Breast Radiotherapy (RT)

RecruitingPhase 3

Sponsor: Weill Medical College of Cornell University

Conditions: Breast Cancer

Interventions: Radiation therapy - 1 week, Radiation therapy - 2 weeks

Countries: United States

This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.

Eligibility overview

Sex: FEMALE

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

New York, New York, United States
New York, New York, United States
New York, New York, United States