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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Stereotactic radiotherapy delivered by CyberKnife; Radiation: stereotactic radiotherapy

• Registration Number: NCT01290835
• Lead Sponsor: Essentia Health

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

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-06
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic radiotherapy	stereotactic radiotherapy	Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Stereotactic radiotherapy	Stereotactic radiotherapy delivered by CyberKnife	Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Essentia Health SMDC Cancer Center; 🇺🇸 Duluth, Minnesota, United States