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NCT Number: NCT01310530

Partial Breast Proton Therapy for Early Stage Breast Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton Beam Radiotherapy

Radiation

Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.

Primary outcomes

  1. Rate of recurrence in the breast

    Time frame: 5 years

Secondary outcomes

  1. Rate of breast recurrence of low versus intermediate risk patients

    Time frame: 5 years

  2. Side-effects related to treatment

    Time frame: 5 years

  3. Disease Free Survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2011
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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