Breast CancerPhase 3PRARTNCT04175210
Prospective Randomized Study of Accelerated Radiation Therapy (PRART)
A Phase 3 study testing Radiation therapy - 3 weeks and Radiation therapy - 2 weeks in people with Breast Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation therapy - 3 weeks and Radiation therapy - 2 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Nov 2019to 30 Jun 2030
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York Presbyterian Hospital at Lower Manhattan Cancer Center
New York, New York, 10007
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, 11215
New York Presbyterian Hospital - Queens
New York, New York, 11355
About this study
Official title: 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).
- Conditions
- Breast Cancer
- Being tested
- Radiation therapy - 3 weeks, Radiation therapy - 2 weeks
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapy - 3 weeksRadiation
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 therapy - 2 weeksRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions | Experimental | 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 Receives: Radiation: Radiation therapy - 3 weeks |
| ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions | Experimental | 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. Receives: Radiation: Radiation therapy - 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1-month post-radiation treatment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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".
Measured: 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."
Measured: 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".
Measured: 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."
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start21 Nov 2019
- Primary completion15 Jul 2025
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Formenti, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175210
- Sponsor's protocol ID
- 19-07020533
- Acronym
- PRART
- Status last verified
- May 2026
- First submitted
- 20 Nov 2019
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04175210
- Acronym / sponsor ID
- PRART / 19-07020533
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions | Experimental | Radiation: Radiation therapy - 3 weeksPatients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions |
| ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions | Experimental | Radiation: Radiation therapy - 2 weeksPatients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapy - 3 weeksPatients 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 | ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions |
| Radiation therapy - 2 weeksPatients 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 | ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions |
Primary outcome
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
Time frame: 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.
6 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Formenti, M.D. principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation therapy - 3 weeks and Radiation therapy - 2 weeks in people with Breast Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: up to 1-month post-radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.