Status:
RECRUITING
Two Versus One Week Breast Radiotherapy (RT)
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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-FO...
Detailed 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...
Eligibility Criteria
Inclusion
- Women status post segmental mastectomy.
- If unilateral, pT1-2 breast cancer excised with negative margins.
- If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
- Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
- Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
- Women with previous contralateral treated breast cancer can be enrolled in the trial.
Exclusion
- Previous radiation therapy to the ipsilateral breast.
- \>90 days from last surgery, unless s/p adjuvant chemotherapy.
- \>60 days from last chemotherapy.
- Male breast cancer.
- Ongoing treatment for severe autoimmune disease.
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2040
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06960707
Start Date
April 29 2025
End Date
December 31 2040
Last Update
July 25 2025
Active Locations (3)
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1
Brooklyn Methodist Hospital
New York, New York, United States, 11215
2
New York Presbyterian Hospital
New York, New York, United States, 11355
3
New York-Presbyterian Weill Cornell Medical College
New York, New York, United States, 11355