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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01290835

Acronym

CKPBI

Enrollment

Registered

2011-02-07

Start date

2010-06-30

Completion date

2025-08-31

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Stereotactic radiotherapy, CyberKnife following lumpectomy, Breast cancer

Brief summary

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).

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

Interventions

RADIATIONStereotactic 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.

RADIATIONstereotactic radiotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.	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

Measure	Time frame	Description
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026