Comparing two radiation therapy schedules for breast cancer using proton therapy

Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)

This study is testing if a shorter three-week proton radiation therapy for breast cancer works just as well and causes the same side effects as the standard five-week treatment for women who have had surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 19 Years and up
• Sex: Female
• Sponsor: Proton Collaborative Group (Research network)
• Drugs / interventions: chemotherapy, radiation
• Locations: 7 sites (Scottsdale, Arizona and 6 other locations)
• Trial ID: NCT05856773 on ClinicalTrials.gov

What this trial studies

This research investigates the effects of hypofractionated proton radiation therapy, which involves a shorter treatment duration of three weeks, compared to the conventional five-week regimen for women with breast cancer. The study aims to determine if the shorter treatment schedule results in similar rates of skin and soft tissue side effects as the longer standard treatment. Patients with Stage I-III breast cancer who have undergone surgery and require postoperative radiation therapy are eligible for participation. The study utilizes advanced proton therapy techniques to target the breast and regional lymph nodes effectively.

Who should consider this trial

Good fit: Ideal candidates are women with Stage I-III breast cancer who have had surgery and are recommended for postoperative radiation therapy.

Not a fit: Patients with metastatic breast cancer or those who have not undergone surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the treatment burden for breast cancer patients while maintaining safety and efficacy.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN)
* Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended
* Documentation of negative metastatic workup by whole body Positron Emission Tomography - Computed Tomography (PET/CT) or by combined CT of the chest, abdomen, pelvis and Bone scan
* History and physical exam within 90 days prior to study registration
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Negative pregnancy test for women of child-bearing potential
* Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy
* Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed
* Bilateral breast cancer is allowed if at least one side will be treated with comprehensive nodal irradiation per protocol treatment and will be recorded as the laterality receiving comprehensive nodal irradiation. If both sides will be treated comprehensively, it will be documented as such

Exclusion Criteria:

* Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease)
* Residual gross disease detected by imaging or clinical exam with the exception of \<2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost
* Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy)
* Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
* Presence of double/dual port tissue expander
* Clinical or radiographic evidence of distant metastatic disease
* Pregnant or breast-feeding females
* Non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
* History of connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
* Known BRCA 1 or BRCA 2 mutation
* Presence of an active skin rash
* 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.

Where this trial is running

Scottsdale, Arizona and 6 other locations

• Mayo Clinic — Scottsdale, Arizona, United States (Recruiting)
• California Protons Cancer Therapy Center — San Diego, California, United States (Recruiting)
• University of Florida Proton Therapy Institute — Jacksonville, Florida, United States (Recruiting)
• Miami Cancer Institute — Miami, Florida, United States (Recruiting)
• Emory Proton Therapy Center — Atlanta, Georgia, United States (Recruiting)
• New York Proton Center — New York, New York, United States (Recruiting)
• Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)

Conditions Breast Cancer; Proton Radiation