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RecruitingPhase 3

Two Versus One Week Breast Radiotherapy (RT)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week, 2 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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")."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares one week of breast radiation with two weeks of radiation plus an extra focused dose. It is for women with early breast cancer who have had part of the breast removed. It will compare side effects, breast appearance, and how well each treatment keeps cancer from coming back in the breast.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women who have had surgery to remove part of the breast.
  • If cancer is in one breast: it must be in tumor size group pT1 or pT2, with no cancer at the edges of the removed tissue.
  • If cancer is in both breasts: it must be pT1 or pT2 cancer and/or pTis cancer (cancer that has not spread beyond where it started), with no cancer at the edges of the removed tissue.
  • Lymph node status must meet one of these rules: no cancer found on an ultrasound exam; pN0–1 (no or limited cancer in nearby lymph nodes); Nx (nodes not assessed); or no cancer in the first draining lymph node.
  • DCIS (cancer inside the milk ducts) is allowed if none is found at the edges of the removed tissue.
  • Women who previously had cancer treated in the other breast may join.

Who can't join

  • Previous radiation to the breast being treated.
  • More than 90 days since the last surgery, unless chemotherapy was given after surgery.
  • More than 60 days since the last chemotherapy treatment.
  • Men with breast cancer.
  • Current treatment for a severe autoimmune disease, in which the body's defenses attack healthy tissue.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

NY