Clinical trial NCT00614172: Proton Therapy for Early Stage Breast Cancer
Official title: Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-Stage Breast Cancer
Keywords: Proton
Radiation
Breast cancer
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ipsilateral Breast Tumor Recurrence-free Survival
timeFrame: Up to 5 years post-treatment completion, average of 48 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 5 years post- completion of treatment, average 48 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
state: California
Study officials:
affiliation: Loma Linda University Department of Radiation Medicine
name: David A. Bush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University Department of Radiation Medicine
name: Jerry D. Slater, MD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.