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


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Catherine C. Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000465214

NCT ID:

NCT00301041

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • invasive ductal breast carcinoma
  • invasive lobular breast carcinoma
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115