NCT03077841

Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer

Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 928 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.

Detailed description

PRIMARY OBJECTIVE: I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen. SECONDARY OBJECTIVES: I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen. II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559. III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer. IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival. V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale. VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.

Conditions

• Ductal Breast Carcinoma In Situ
• Early-Stage Breast Carcinoma
• Invasive Breast Carcinoma
• Stage 0 Breast Cancer AJCC v6 and v7
• Stage I Breast Cancer AJCC v7
• Stage IA Breast Cancer AJCC v7
• Stage IB Breast Cancer AJCC v7
• Stage II Breast Cancer AJCC v6 and v7
• Stage IIA Breast Cancer AJCC v6 and v7
• Stage IIB Breast Cancer AJCC v6 and v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Partial Breast Irradiation	Undergo hypofractionated partial breast irradiation
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-03-06
• Primary completion: 2027-11-08
• Completion: 2027-11-08
• First posted: 2017-03-13
• Last updated: 2026-03-05

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study