Radiation Therapy in Treating Women With Invasive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301041
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : August 21, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: laboratory biomarker analysis Procedure: adjuvant therapy Radiation: radiation therapy Early Phase 1

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Relationship Between Plasma Transforming Growth Factor-beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study
Study Start Date : April 2004
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • No prior breast radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301041

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Catherine C. Park, MD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT00301041     History of Changes
Other Study ID Numbers: CDR0000465214
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by University of California, San Francisco:
invasive ductal breast carcinoma
invasive lobular breast carcinoma
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases