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NCT Number: NCT06960707

Two Versus One Week Breast Radiotherapy (RT)

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Brooklyn Methodist Hospital, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (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.

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.
  • Ongoing treatment for severe autoimmune disease.

Treatment and study plan

Radiation therapy - 1 week

Radiation

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

Radiation therapy - 2 weeks

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:

    • Mild
    • Moderate
    • Severe
    • Life-threatening

  2. 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:

    • = No difference between treated and untreated breast/area
    • = Slight difference
    • = Moderate difference
    • = Large difference

  3. 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.

  4. 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:

    • Mild
    • Moderate
    • Severe
    • Life-threatening

  5. 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:

    • = No difference between treated and untreated breast/area
    • = Slight difference
    • = Moderate difference
    • = Large difference

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabiana Gregucci, MD

CONTACT

[email protected]

6469623110

Fereshteh Talebi, MD

CONTACT

[email protected]

6467027830

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Acronym: PRATO

Important dates

Study start
2025
Primary completion
2030
Study completion
2040
First posted
May 7, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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