Proton Therapy for Early Stage Breast Cancer

August 24, 2023 updated by: David Bush, Loma Linda University

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

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton Radiotherapy
Two week course of proton radiotherapy to the breast.
Radiation: Proton radiation therapy
Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral Breast Tumor Recurrence-free Survival
Time Frame: Up to 5 years post-treatment completion, average of 48 months
Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam
Up to 5 years post-treatment completion, average of 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 5 years post- completion of treatment, average 48 months
Overall survival rate at 5 years post-treatment completion.
Up to 5 years post- completion of treatment, average 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: David A. Bush, MD, Loma Linda University Department of Radiation Medicine
  • Study Chair: Jerry D. Slater, MD, Loma Linda University Department of Radiation Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

May 12, 2020

Study Completion (Actual)

May 12, 2020

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimated)

February 13, 2008

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53294 (Research Manitoba)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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