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Two Versus One Week Breast Radiotherapy (RT)

Description

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.

Conditions

Breast Cancer
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Related Conditions:

Breast Cancer

Study Overview

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Study Details

Study overview

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.

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

Two Versus One Week Breast Radiotherapy (RT)

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Brooklyn Methodist Hospital, New York, New York, United States, 11215

New York

New York Presbyterian Hospital, New York, New York, United States, 11355

New York

New York-Presbyterian Weill Cornell Medical College, New York, New York, United States, 11355

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Silvia C. Formenti, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2040-12-31