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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Early-Stage Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the survival and recurrence rates associated with partial breast proton therapy.

Outcome Time Frame:

Every 3 months

Safety Issue:

Yes

Principal Investigator

David A. Bush, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Department of Radiation Medicine

Authority:

United States: Institutional Review Board

Study ID:

OSR# 53294

NCT ID:

NCT00614172

Start Date:

February 2004

Completion Date:

December 2014

Related Keywords:

  • Early-Stage Breast Cancer
  • Proton
  • Radiation
  • Breast cancer
  • Breast Neoplasms

Name

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