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Completed

NCT Number: NCT01290835

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

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).

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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

60 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Essentia Health SMDC Cancer Center

Duluth, Minnesota, 55805, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Prior radiotherapy to the breast
  • Neoadjuvant chemotherapy
  • multicentric disease
  • Pure DCIS histology
  • Presence of extensive intraductal component
  • Node positive disease (N1 or greater)

Treatment and study plan

Stereotactic radiotherapy delivered by CyberKnife

Radiation

Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.

Other names: CyberKnife

Stereotactic radiotherapy

Radiation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Essentia Health

Other

Registry information

Acronym: CKPBI

Important dates

Study start
2010
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2011
Registry last updated
Aug 15, 2025

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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