Recruiting

Two Versus One Week Breast Radiotherapy (RT)

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…

ClinicalTrials.gov IDNCT06960707

PhasePHASE3

Enrollment400

SponsorWeill Medical College of Cornell University

AgeNo minimum reported

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

Interventions

Radiation: Radiation therapy - 1 week — 2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
Radiation: Radiation therapy - 2 weeks — 3200 cGy whole breast radiotherapy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 2) over 2 weeks. 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.

Primary outcomes

Rate of RT-related acute toxicity (1 month)

Eligibility information

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.

Study locations

Brooklyn Methodist Hospital, New York, New York 11215 United States
New York Presbyterian Hospital, New York, New York 11355 United States
New York-Presbyterian Weill Cornell Medical College, New York, New York 11355 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.