OncoMatch/Clinical Trials/NCT05856773
Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
Official title: Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)
Is NCT05856773 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies non-drug interventions for breast cancer.
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Excluded: BRCA1 mutation
Excluded: BRCA2 mutation
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: radiation therapy overlapping with current target volume
Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy)
Cannot have received: explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
Cannot have received: prior history of breast cancer
Prior history of breast cancer
Cannot have received: prior invasive non-study malignancy
Exception: disease free for ≥ 3 years; non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible
Prior invasive non-study malignancy unless disease free for ≥ 3 years. Non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Scottsdale, Arizona
- California Protons Cancer Therapy Center · San Diego, California
- University of Florida Proton Therapy Institute · Jacksonville, Florida
- Dwoskin Proton Therapy Center · Miami, Florida
- Miami Cancer Institute · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05856773 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy overlapping with current target volume, explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction, prior history of breast cancer disqualifies patients from enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 mutation is an exclusion criterion.
What disease stage is eligible?
Stage I or II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages