Partial Breast Proton Therapy for Early Stage Breast Cancer

NCT ID: NCT01310530

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-04
• Study Completion Date: 2025-12-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial Breast Proton Therapy

Two weeks of daily proton therapy delivered to the lumpectomy site.

Group Type: EXPERIMENTAL

Proton Beam Radiotherapy

Intervention Type: RADIATION

Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.

Interventions

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.

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Bush, MD

Role: PRINCIPAL_INVESTIGATOR

Radiation Medicine - Loma Linda University Medical Center

Locations

Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.

Loma Linda, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

References

Bush DA, Slater JD, Garberoglio C, Yuh G, Hocko JM, Slater JM. A technique of partial breast irradiation utilizing proton beam radiotherapy: comparison with conformal x-ray therapy. Cancer J. 2007 Mar-Apr;13(2):114-8. doi: 10.1097/PPO.0b013e318046354b.

Reference Type: BACKGROUND

PMID: 17476139 (View on PubMed)

Other Identifiers

5110026

Identifier Type: -

Identifier Source: org_study_id