Partial Breast Proton Therapy for Early Stage Breast Cancer

Loma Linda University (LLU)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Radiation: Proton Beam Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01310530

5110026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Partial Breast Proton Therapy

Experimental group

Description:

Two weeks of daily proton therapy delivered to the lumpectomy site.

Treatment:

Radiation: Proton Beam Radiotherapy