This trial is active, not recruiting.

Condition breast cancer
Treatment proton beam radiotherapy
Phase phase 2
Sponsor Loma Linda University
Start date May 2011
End date May 2023
Trial size 150 participants
Trial identifier NCT01310530, 5110026


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Two weeks of daily proton therapy delivered to the lumpectomy site.
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.

Primary Outcomes

Rate of recurrence in the breast
time frame: 5 years

Secondary Outcomes

Rate of breast recurrence of low versus intermediate risk patients
time frame: 5 years
Side-effects related to treatment
time frame: 5 years
Disease Free Survival
time frame: 5 years

Eligibility Criteria

Female participants from 40 years up to 80 years old.

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

Additional Information

Official title Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
Principal investigator David A Bush, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Loma Linda University.