NCT00614172

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

16.3 years

First QC Date

December 26, 2007

Results QC Date

August 3, 2023

Last Update Submit

August 24, 2023

Conditions

Early-Stage Breast Cancer

Keywords

ProtonRadiationBreast cancer

Outcome Measures

Primary Outcomes (1)

  • Ipsilateral Breast Tumor Recurrence-free Survival

    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 Outcomes (1)

  • Overall Survival

    Up to 5 years post- completion of treatment, average 48 months

Study Arms (1)

Proton Radiotherapy

EXPERIMENTAL

Two week course of proton radiotherapy to the breast.

Radiation: Proton radiation therapy

Interventions

Proton radiation therapyRADIATION

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.

Proton Radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.

Loma Linda, California, 92354, United States

Location

Related Publications (3)

  • 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.

    PMID: 17476139RESULT

  • Bush DA, Slater JD, Garberoglio C, Do S, Lum S, Slater JM. Partial breast irradiation delivered with proton beam: results of a phase II trial. Clin Breast Cancer. 2011 Aug;11(4):241-5. doi: 10.1016/j.clbc.2011.03.023. Epub 2011 Jun 12.

    PMID: 21729673RESULT

  • Bush DA, Do S, Lum S, Garberoglio C, Mirshahidi H, Patyal B, Grove R, Slater JD. Partial breast radiation therapy with proton beam: 5-year results with cosmetic outcomes. Int J Radiat Oncol Biol Phys. 2014 Nov 1;90(3):501-5. doi: 10.1016/j.ijrobp.2014.05.1308. Epub 2014 Jul 30.

    PMID: 25084608RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Protons

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Results Point of Contact

Title
David Bush, MD, Vice Chair Clinical Affairs Radiation Medicine
Organization
Loma Linda University Health
DBush@llu.edu
909 558 1000

Study Officials

  • David A. Bush, MD

    Loma Linda University Department of Radiation Medicine

    PRINCIPAL INVESTIGATOR

  • Jerry D. Slater, MD

    Loma Linda University Department of Radiation Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inverstigator

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 13, 2008

Study Start

February 1, 2004

Primary Completion

May 12, 2020

Study Completion

May 12, 2020

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2023-08

Locations

US(1)