Accelerated radiation therapy for early-stage breast cancer
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)
This study is testing if a shorter radiation treatment for early-stage breast cancer can be just as effective as the standard longer treatment, making it easier for women to manage their care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT04175210 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of accelerated radiation therapy for women with early-stage breast cancer, specifically those with Stage 0 ductal carcinoma in situ and Stage T1-T2 lymph node negative breast cancers. Participants will be randomly assigned to receive either the standard treatment of whole breast radiotherapy over 15 fractions or an experimental approach over 10 fractions. The goal is to determine if the shorter treatment duration is equally effective while potentially improving patient convenience and quality of life.
Who should consider this trial
Good fit: Ideal candidates are women who have undergone segmental mastectomy for early-stage breast cancer with negative margins.
Not a fit: Patients who have previously received radiation therapy to the affected breast or who are male may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient radiation therapy regimen for early-stage breast cancer patients, reducing treatment time without compromising effectiveness.
How similar studies have performed: Other studies have shown promising results with accelerated radiation therapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 or pN0 or sentinel node negative * Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins). 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
Where this trial is running
New York, New York and 2 other locations
- New York Presbyterian Hospital at Lower Manhattan Cancer Center — New York, New York, United States (Recruiting)
- Brooklyn Methodist Hospital - NewYork Presbyterian — New York, New York, United States (Recruiting)
- New York Presbyterian Hospital - Queens — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Silvia Formenti, M.D. — Weill Medical College of Cornell University
- Study coordinator: Sharanya Chandrasekhar
- Email: shc2043@med.cornell.edu
- Phone: 6469623110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.