Radiation Therapy in Treating Women With Invasive Breast Cancer - Full Text View

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301041

Purpose

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.

Condition	Intervention
Breast Cancer	Other: laboratory biomarker analysis Procedure: adjuvant therapy Radiation: radiation therapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	The Relationship Between Plasma Transforming Growth Factor-Beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	100
Study Start Date:	April 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301041

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Catherine C. Park, MD

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000465214, UCSF-03756, UCSF-H11164-24300-02
Study First Received:	March 8, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00301041 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Carcinoma, Lobular
Skin Diseases
Adjuvants, Immunologic
Mitogens

Breast Neoplasms
Carcinoma, Ductal, Breast
Breast Diseases
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009