Overview

This trial is active, not recruiting.

Condition early-stage breast cancer
Treatment proton radiation therapy
Phase phase 2
Sponsor Loma Linda University
Start date February 2004
End date December 2019
Trial size 150 participants
Trial identifier NCT00614172, 53294

Summary

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Two week course of proton radiotherapy to the breast.
proton radiation therapy
Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.

Primary Outcomes

Measure
Determine the survival and recurrence rates associated with partial breast proton therapy.
time frame: Every 3 months

Secondary Outcomes

Measure
To evaluate the toxicity and the cosmetic results with partial breast proton therapy. To determine the local tumor control and survival associated with partial breast proton therapy
time frame: Every 3 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Invasive ductal, medullary, papillary, colloid or tubular histologies - Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen. - No more then 3 positive nodes on axillary dissection or negative sentinel node. - Negative surgical margins (>2mm) Exclusion Criteria: - Invasive lobular histology - Previous chemotherapy for breast cancer - Extensive intraductal component - Collagen vascular disease - Prior malignancy unless disease-free for 5 years - Patients who are pregnant or lactating

Additional Information

Official title Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer
Principal investigator David A. Bush, MD
Description Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Loma Linda University.