Prospective Randomized Study of Accelerated Radiation Therapy (PRART) (PRART)

Prospective Randomized Study of Accelerated Radiation Therapy (PRART) : A Non-Inferiority Trial to Compare Breast Cosmesis and Local Control After Concomitant Boost Breast Radiotherapy With Fifteen Fractions in Three Weeks (Arm 1, Standard) Versus Ten Fractions in Two Weeks (Arm 2, Experimental)

Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Radiation therapy - 3 weeks; Radiation: Radiation therapy - 2 weeks

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • Brooklyn Methodist Hospital - NewYork Presbyterian
    • New York, New York, United States, 11355
      • New York Presbyterian Hospital - Queens
    • New York, New York, United States, 10007
      • New York Presbyterian Hospital at Lower Manhattan Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 or pN0 or sentinel node negative
• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
• Women with previous contralateral breast cancer.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions; Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions	Radiation: Radiation therapy - 3 weeks; Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions
Experimental: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions; Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.	Radiation: Radiation therapy - 2 weeks; Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment	Proportion of grade ≥ 2 of acute toxicity defined according to the Common Terminology Criteria for Adverse Events (CTCAEs) - version 5.0, on the 10-fraction arm compared to the rate on the 15-fraction arm will be measured, up to 1-month post-radiation treatment.	up to 1-month post-radiation treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment	Assess and compare local control at 2-3 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breast clinical recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breast MRI.	2-3 years
Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment	Assess and compare local control at 5 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breasts clinical disease recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breasts MRI.	5 years
Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment	Assess and compare fibrosis at 2-3 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation".	2-3 years
Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment	Assess and compare breast cosmesis at 2-3 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast."	2-3 years
Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment	Assess and compare fibrosis at 5 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation".	5 years
Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment	Assess and compare breast cosmesis at 5 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast."	5 years

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Silvia Formenti, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): July 15, 2025
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Radiotherapy
• Other Study ID Numbers: 19-07020533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No