Radiation Therapy in Treating Women With Invasive Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00301041
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 (TGF-β) in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy.
Secondary
* Establish longitudinal serum and plasma biorepository for retrospective evaluation of TGF-β and other biomarkers with special relevance to radiation response.
* Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
* Arm I (hypofractionated radiotherapy): Patients undergo external-beam radiotherapy once daily 5 days a week for up to 3.5 weeks (16 fractions total).
* Arm II (standard fractionated radiotherapy): Patients undergo radiotherapy as in arm I at a lower dose for up to 5 weeks (25 fractions total).
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States