Partial Breast Proton Therapy for Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01310530
• Other study ID #: 5110026
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2011
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.

Description:

Radiation therapy delivered to the whole breast is standard treatment following tumor removal for patients with early stage breast cancer. In selected patients, delivering the radiation treatment to only the part of the breast involved by the tumor may be a viable alternative. This can decrease the amount of normal tissues exposed to irradiation, potentially decrease side-effects and shorten the treatment time. Proton beam can decrease the volume of normal tissues treated compared to standard forms of radiotherapy. This study will recruit patients with early stage breast cancer following surgical removal to undergo partial breast radiotherapy with proton beam and determine the recurrence rates and side-effects of treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Breast carcinoma

• DCIS

• Age 40 years or higher

• Primary tumor 3 cm or less

• Lumpectomy with clip placement

• Axillary node sampling

• Negative margins

Exclusion Criteria:

• Distant metastasis

• Multicentric disease

• Prior radiation or chemotherapy

• Active collagen vascular disease

• Pregnant or lactating

• BRCA mutation

• Lymph nodes with more than microscopic tumor involvement

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Proton Beam Radiotherapy
Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California
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 (1)

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	Rate of recurrence in the breast		5 years
Secondary	Rate of breast recurrence of low versus intermediate risk patients		5 years
Secondary	Side-effects related to treatment		5 years
Secondary	Disease Free Survival		5 years