What this study is
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.
What's being tested
- Radiation therapy - 1 week
Intervention · RADIATION
2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
- Radiation therapy - 2 weeks
Intervention · RADIATION
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.
Study details
- Official title
- Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Breast Cancer
- Enrolling
- 400 people
- Starts
- 2025-04-29
- Est. completion
- 2040-12-31
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openBrooklyn Methodist Hospital
New York, New York, United States
- Izael Nino · Contact(929) 470-9426izn4001@med.cornell.edu
- Hani Ashamalla, MD · Principal investigator
RecruitingNew York Presbyterian Hospital
New York, New York, United States
- Krystalle Lyons · Contact718-670-1541krl4003@med.cornell.edu
- Steven DiBiase, MD · Principal investigator
RecruitingNew York-Presbyterian Weill Cornell Medical College
New York, New York, United States
- Maahi Patel, Bachelors of Science, BS · Contact9784025630map4044@med.cornell.edu
- Fabiana Gregucci, MD · Contact
- Silvia C. Formenti, MD · Principal investigator
Recruiting
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 25-01028391
Principal investigator
Silvia C. Formenti, MD
Weill Medical College of Cornell University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.