Two Versus One Week Breast Radiotherapy (RT)

Last updated: July 24, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Radiation therapy - 1 week

Radiation therapy - 2 weeks

Clinical Study ID

NCT06960707
25-01028391
  • Female

Study Summary

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 Criteria

Inclusion

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 excisedwith negative margins.

  4. Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx orsentinel 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 thetrial.

Exclusion

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.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Radiation therapy - 1 week
Phase: 3
Study Start date:
April 29, 2025
Estimated Completion Date:
December 31, 2040

Study Description

Radiotherapy: one week (Arm 1) 2600 cGy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (Arm 2), 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.

Hypothesis: A regimen of whole breast radiotherapy to 2600 in five fractions, the current UK standard for early breast cancer (Arm 2), is not inferior to 3200cGy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. It will also test the hypothesis of superior local control at 10 years in Arm 2 compared to Arm 1.

Connect with a study center

  • Brooklyn Methodist Hospital

    New York, New York 11215
    United States

    Active - Recruiting

  • New York Presbyterian Hospital

    New York, New York 11355
    United States

    Active - Recruiting

  • New York-Presbyterian Weill Cornell Medical College

    New York, New York 11355
    United States

    Active - Recruiting

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