Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I/II Feasibility Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Washington University School of Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity
Time Frame: Within 1 year of protocol registration
-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity
Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan
Time Frame: Within 1 year of protocol registration
-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
Secondary Outcomes
- Local Control Rate(Up to 5 years)
- Distant Control Rate(Up to 5 years)
- Incidence and Severity of Cutaneous Toxicity(Up to 5 years)
- Incidence of Fat Necrosis(Up to 5 years)
- Incidence of Breast Fibrosis(Up to 5 years)
- Cosmetic Outcome(Up to 5 years)
- Regional Control Rate(Up to 5 years)