Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer (CKPBI)

August 13, 2025 updated by: Ken Dornfeld, Essentia Health
The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer

Study Type

Interventional

Enrollment (Actual)

20

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
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health SMDC Cancer Center

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

60 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of breast malignancy, stage T1
  2. Surgical treatment with lumpectomy
  3. age 60 or older
  4. resection margins negative by at least 2mm
  5. any grade
  6. ER positive
  7. unicentric
  8. invasive ductal
  9. pathologic free of nodal metastases (N0, i- or i+)
  10. Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%

Exclusion criteria

  1. Prior radiotherapy to the breast
  2. Neoadjuvant chemotherapy
  3. multicentric disease
  4. Pure DCIS histology
  5. Presence of extensive intraductal component
  6. Node positive disease (N1 or greater)

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: Stereotactic radiotherapy
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Radiation: Stereotactic radiotherapy delivered by CyberKnife
Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.
Other Names:
  • CyberKnife
Radiation: stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
Time Frame: one year
Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treated while also respecting normal tissue tolerances.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
Time Frame: 1 year
Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammography or screening breast MRaI for 5 years.
1 year

Collaborators and Investigators

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

Sponsor

Essentia Health

Investigators

  • Principal Investigator: Ken Dornfeld, MD, Essentia Health Oncology

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

June 1, 2010

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

February 4, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (Estimated)

February 7, 2011

Study Record Updates

Last Update Posted (Actual)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMDC10101

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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