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RecruitingInterventionalPhase 3

Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)

NCT ID: NCT06960707Sponsor: Weill Medical College of Cornell UniversityLast updated: 2026-06-15

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.

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, 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.

Arms & interventions

  • RadiationRadiation therapy - 1 week

    2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week

  • RadiationRadiation 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.

Outcome measures

Primary

  • Rate of RT-related acute toxicity

    The rate of RT-related acute toxicity is defined as cumulative acute toxicity events from the start of radiation treatment to 1 month follow up post RT. The toxicities will be graded by the research nurses assigned to the study according to Common Terminology Criteria for Adverse Events, version 5.0.

    Time frame: 1 month

Secondary

  • The long-term evaluations at 2 years of fibrosis based on LENT/SOMA

    Time frame: 24 months

  • The long-term evaluations at 2 years of breast cosmesis

    Time frame: 24 months

  • The long-term evaluations at 2 years of local control

    Time frame: 24 months

  • The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA

    Time frame: 60 months

  • The long-term evaluations at 5 years of breast cosmesis

    Time frame: 60 months

  • The long-term evaluations at 5 years of local control.

    Time frame: 60 months

  • Superior local control at 10 years

    Time frame: 120 months

Eligibility criteria

Sex: FemaleAge: All agesHealthy volunteers: No
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 (3)

Brooklyn Methodist Hospital

New York, New York, 11215

Recruiting
Izael Nino · Contact
(929) 470-9426izn4001@med.cornell.edu
Hani Ashamalla, MD · Principal Investigator

New York Presbyterian Hospital

New York, New York, 11355

Recruiting
Krystalle Lyons · Contact
718-670-1541krl4003@med.cornell.edu
Steven DiBiase, MD · Principal Investigator

New York-Presbyterian Weill Cornell Medical College

New York, New York, 11355

Recruiting
Maahi Patel, Bachelors of Science, BS · Contact
9784025630map4044@med.cornell.edu
Fabiana Gregucci, MD · Contact
Silvia C. Formenti, MD · Principal Investigator