Two Versus One Week Breast Radiotherapy (RT) (PRATO)

July 24, 2025 updated by: Weill Medical College of Cornell University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11215
        • Recruiting
        • Brooklyn Methodist Hospital
        • Principal Investigator:
          • Hani Ashamalla, MD
        • Contact:
      • New York, New York, United States, 11355
        • Recruiting
        • New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Steven DiBiase, MD
      • New York, New York, United States, 11355
        • Recruiting
        • New York-Presbyterian Weill Cornell Medical College
        • Contact:
        • Contact:
          • Fabiana Gregucci, MD
        • Principal Investigator:
          • Silvia C. Formenti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARM 1-2600 cGy in 5 fractions whole breast radiotherapy
Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week
Radiation: Radiation therapy - 1 week
2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
Experimental: ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy
Patients randomized to ARM 2 will receive 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy.
Radiation: Radiation 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of RT-related acute toxicity
Time Frame: 1 month
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.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The long-term evaluations at 2 years of fibrosis based on LENT/SOMA
Time Frame: 24 months

The number of subjects scoring Grades 1 through 4 using the LENT/SOMA (Late Effects Normal Tissues (LENT)-Subjective, Objective, Management, Analytic (SOMA)) system will be reported.

The patients will grade the following items based on the following scale:

  1. Mild
  2. Moderate
  3. Severe
  4. Life-threatening
24 months
The long-term evaluations at 2 years of breast cosmesis
Time Frame: 24 months

Patient self-reported breast cosmesis will be assessed using the BCTOS questionnaire (Breast Cancer Treatment Outcome Scale).The number of subjects scoring Grades 1 through 4 will be reported. The patients will grade the following items based on the following scale:

  1. = No difference between treated and untreated breast/area
  2. = Slight difference
  3. = Moderate difference
  4. = Large difference
24 months
The long-term evaluations at 2 years of local control
Time Frame: 24 months
Number of subjects with Local control at 2 years will be extracted from the medical record, and can be derived from clinical reports from medical, surgical or radiation oncologists as well as from the primary care doctor who is following the patient.
24 months
The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA
Time Frame: 60 months

The number of subjects scoring Grades 1 through 4 using the LENT/SOMA (Late Effects Normal Tissues (LENT)-Subjective, Objective, Management, Analytic (SOMA)) system will be reported.

The patients will grade the following items based on the following scale:

  1. Mild
  2. Moderate
  3. Severe
  4. Life-threatening
60 months
The long-term evaluations at 5 years of breast cosmesis
Time Frame: 60 months

Patient self-reported breast cosmesis will be assessed using the BCTOS questionnaire (Breast Cancer Treatment Outcome Scale). The number of subjects scoring Grades 1 through 4 will be reported. The patients will grade the following items based on the following scale:

  1. = No difference between treated and untreated breast/area
  2. = Slight difference
  3. = Moderate difference
  4. = Large difference
60 months
The long-term evaluations at 5 years of local control.
Time Frame: 60 months
Number of subjects with Local control at 5 years will be extracted from the medical record, and can be derived from clinical reports from medical, surgical or radiation oncologists as well as from the primary care doctor who is following the patient.
60 months
Superior local control at 10 years
Time Frame: 120 months
Number of subjects with Local control at 10 years will be extracted from the medical record, and can be derived from clinical reports from medical, surgical or radiation oncologists as well as from the primary care doctor who is following the patient.
120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia C. Formenti, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-01028391

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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