Proton Therapy for Early Stage Breast Cancer

Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer

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

Study Overview

• Status: Completed
• Conditions: Early-Stage Breast Cancer
• Intervention / Treatment: Radiation: Proton radiation therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proton Radiotherapy; Two week course of proton radiotherapy to the breast.	Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral Breast Tumor Recurrence-free Survival	Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam	Up to 5 years post-treatment completion, average of 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival rate at 5 years post-treatment completion.	Up to 5 years post- completion of treatment, average 48 months

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: David A. Bush, MD, Loma Linda University Department of Radiation Medicine; Study Chair: Jerry D. Slater, MD, Loma Linda University Department of Radiation Medicine

Publications and helpful links

General Publications

• 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.
• Bush DA, Slater JD, Garberoglio C, Do S, Lum S, Slater JM. Partial breast irradiation delivered with proton beam: results of a phase II trial. Clin Breast Cancer. 2011 Aug;11(4):241-5. doi: 10.1016/j.clbc.2011.03.023. Epub 2011 Jun 12.
• Bush DA, Do S, Lum S, Garberoglio C, Mirshahidi H, Patyal B, Grove R, Slater JD. Partial breast radiation therapy with proton beam: 5-year results with cosmetic outcomes. Int J Radiat Oncol Biol Phys. 2014 Nov 1;90(3):501-5. doi: 10.1016/j.ijrobp.2014.05.1308. Epub 2014 Jul 30.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimated): February 13, 2008

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Radiation; Proton
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 53294 (Research Manitoba)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes