Radiation Therapy in Treating Women With Invasive Breast Cancer

The Relationship Between Plasma Transforming Growth Factor-beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00301041

Enrollment

Registered

2006-03-10

Start date

2004-04-30

Completion date

2004-05-31

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

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.

Interventions

OTHERlaboratory biomarker analysis

PROCEDUREadjuvant therapy

RADIATIONradiation therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior breast radiotherapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026