Partial Breast Proton Therapy for Early Stage Breast Cancer

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01310530

Enrollment

150

Registered

2011-03-08

Start date

2011-05-04

Completion date

2026-12-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Partial Breast, Proton Beam

Brief 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.

Detailed 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.

Interventions

RADIATIONProton 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Rate of recurrence in the breast	5 years

Secondary

Measure	Time frame
Rate of breast recurrence of low versus intermediate risk patients	5 years
Side-effects related to treatment	5 years
Disease Free Survival	5 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid A Bush, MD

Radiation Medicine - Loma Linda University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026