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Partial Breast Proton Therapy for Early Stage Breast Cancer

This study is currently recruiting participants.
Verified May 2013 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
David Bush, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01310530
First received: March 7, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.


Condition Intervention Phase
Breast Cancer
Early Stage
 Radiation: Proton Beam Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Rate of recurrence in the breast [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Complication rate in the breast, chest wall and skin [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of breast recurrence of low versus intermediate risk patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Partial Breast Proton Therapy
Two weeks of daily proton therapy delivered to the lumpectomy site.
 Radiation: Proton Beam Radiotherapy
Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.

Detailed Description:

Radiation therapy delivered to the whole breast is standard treatment following tumor removal for patients with early stage breast cancer. In selected patients, delivering the radiation treatment to only the part of the breast involved by the tumor may be a viable alternative. This can decrease the amount of normal tissues exposed to irradiation, potentially decrease side-effects and shorten the treatment time. Proton beam can decrease the volume of normal tissues treated compared to standard forms of radiotherapy. This study will recruit patients with early stage breast cancer following surgical removal to undergo partial breast radiotherapy with proton beam and determine the recurrence rates and side-effects of treatment.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast carcinoma
  • DCIS
  • Age 40 years or higher
  • Primary tumor 3 cm or less
  • Lumpectomy with clip placement
  • Axillary node sampling
  • Negative margins

Exclusion Criteria:

  • Distant metastasis
  • Multicentric disease
  • Prior radiation or chemotherapy
  • Active collagen vascular disease
  • Pregnant or lactating
  • BRCA mutation
  • Lymph nodes with more than microscopic tumor involvement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310530

Contacts
Contact: David A Bush, MD 909-558-4280 dbush@dominion.llumc.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: David A Bush, MD     909-558-4280     dbush@dominion.llumc.edu    
Principal Investigator: David A Bush, MD            
Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St. Recruiting
Loma Linda, California, United States, 92354
Contact: David A. Bush, MD     909-558-4280     dbush@dominion.llumc.edu    
Contact: Jerry D. Slater, MD     909-558-4258     jdslater@dominion.llumc.edu    
Principal Investigator: David A. Bush, MD            
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: David A Bush, MD Radiation Medicine - Loma Linda University Medical Center
  More Information

Publications:

Responsible Party: David Bush, Principal Inverstigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01310530     History of Changes
Other Study ID Numbers: OSR #5110026
Study First Received: March 7, 2011
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Breast Cancer
Partial Breast
Proton Beam

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

ClinicalTrials.gov processed this record on May 21, 2013