Back to resultsPartial Breast Proton Therapy for Early Stage Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Partial Breast, Proton Beam
Eligibility Criteria
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
Sites / Locations
- Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Partial Breast Proton Therapy
Arm Description
Two weeks of daily proton therapy delivered to the lumpectomy site.
Outcomes
Primary Outcome Measures
Rate of recurrence in the breast
Secondary Outcome Measures
Rate of breast recurrence of low versus intermediate risk patients
Side-effects related to treatment
Disease Free Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01310530
Brief Title
Partial Breast Proton Therapy for Early Stage Breast Cancer
Official Title
Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2011 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Partial Breast, Proton Beam
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partial Breast Proton Therapy
Arm Type
Experimental
Arm Description
Two weeks of daily proton therapy delivered to the lumpectomy site.
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiotherapy
Intervention Description
Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.
Primary Outcome Measure Information:
Title
Rate of recurrence in the breast
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of breast recurrence of low versus intermediate risk patients
Time Frame
5 years
Title
Side-effects related to treatment
Time Frame
5 years
Title
Disease Free Survival
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Bush, MD
Organizational Affiliation
Radiation Medicine - Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17476139
Citation
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.
Results Reference
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Learn more about this trial
Partial Breast Proton Therapy for Early Stage Breast Cancer
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