Proton Therapy for Early Stage Breast Cancer

Early-Stage Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614172
• Other study ID #: 53294
• Status: Completed
• Phase: N/A
• Start date: February 2004
• Est. completion date: May 12, 2020

Study information

• Verified date: August 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-Stage Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	Overall survival rate at 5 years post-treatment completion.	Up to 5 years post- completion of treatment, average 48 months