Adult Clinical Trials: BREAST
A Phase III Study of Conventional Whole Breast Irradiation versus Partial Breast Irradiation for Women with Stage 0, 1 or 2 Breast Cancer
Arm I: WBI 45-50Gy in 25 fraction to whole breast followed by optional boost to 60Gy
Arm II: PBI: 34Gy in 3.4Gy fractions using multi-catheter brachytherapy or 34 Gy using MammoSite balloon catheter.
A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for
Early-Stage Breast Cancer
Patient’s stage of breast cancer must be one of the following categories:
- Breast cancer stage I, II and at least one of the following: Positive axillary nodes, under 50 years old, lymphovascular space invasion, non-hormone sensitive cancer, Grade III histology, oncotype score >25. OR
- Stage 0 breast cancer with nuclear grade 3 DCIS and under 50 years old. OR
- Stage 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy.
All surgeries and chemotherapy must be completed within 42 days of study entry.
No T4, N2or N3, or M1 breast cancer accepted in this trial.
Treatment plan includes regional node irradiation are ineligible.
Paget’s disease or the nipple and male breast cancer are ineligible.
Arm I: Standard fractionation whole breast optional fractionation and sequential boost
Arm II: Hypofractionation whole breast and concurrent boost
A Phase II study of Repeat Breast Preserving Surgery and 3D-Conformal
Partial Breast ReIrradiation (PBrI) for Local Recurrence of Breast
Patient population includes the following:
• Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence.
• Final breast surgery within 42 days prior to study entry.
• Initial lumpectomy followed by whole breast radiation greater than one year prior to study entry.
• Bilateral breast mammogram and bilateral breast MRI within 120 days prior to study entry.
• Negative histologic margins of resection, no tumor on ink, following breast-preserving surgery of local recurrence.
• Recurrent tumor size less than 3cm and axilla negative or less than 3 positive lymph nodes without extracapsular extension.
• No skin involvement, paget’s disease or patients with collagenous diseases.
Partial Breast Re-Irradiation (PBrl) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy