Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Francisco
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Underwent lumpectomy (breast-preserving surgery) with or without adjuvant chemotherapy within the past 12 weeks
* Histologically negative surgical margins (i.e., no tumor on ink)
Candidates for postoperative breast radiotherapy
* Determined not to need radiotherapy to regional nodes (e.g., third supraclavicular field)
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Female
Menopausal status not specified
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of scleroderma or systemic lupus erythematosis
No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
