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Radiation Therapy

Partial Breast Irradiation with CyberKnife for Breast Cancer (CKPBI Trial)

N/A
Waitlist Available
Led By Ken Dornfeld, MD
Research Sponsored by Essentia Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Resection margins negative by at least 2mm
ER positive
Must not have
Presence of extensive intraductal component
Multicentric disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether it is safe and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.

Who is the study for?
This trial is for individuals aged 60 or older with early-stage breast cancer, specifically unicentric invasive ductal malignancy at stage T1. Participants must have had a lumpectomy with clear margins of at least 2mm and no nodal metastases (N0). They should not have received prior radiotherapy to the breast, chemotherapy before surgery, or have multicentric disease or node-positive disease.
What is being tested?
The study tests if CyberKnife stereotactic radiotherapy is a feasible and safe option for partial breast irradiation after lumpectomy. It involves ten sessions over five days. The focus will be on short-term and long-term safety as well as effectiveness in tumor control and potential failure sites.
What are the potential side effects?
Potential side effects may include skin reactions, fatigue, changes in breast appearance, pain or discomfort at the treatment site, and rare risks associated with radiation such as secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer surgery removed all visible cancer with a clear margin of at least 2mm.
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My cancer is estrogen receptor positive.
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My cancer has not spread to my lymph nodes.
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I have had a lumpectomy.
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My breast cancer is in the early stage (T1).
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I am 60 years old or older.
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The area treated with lumpectomy is less than 30% of my whole breast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer has a significant intraductal component.
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My cancer is present in multiple locations within the same organ.
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My cancer has spread to nearby lymph nodes.
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I have received chemotherapy before surgery.
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I have had radiation therapy to the breast before.
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My breast cancer is diagnosed as DCIS only.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
Secondary study objectives
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic radiotherapyExperimental Treatment2 Interventions
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic radiotherapy
2014
N/A
~60

Find a Location

Who is running the clinical trial?

Essentia HealthLead Sponsor
26 Previous Clinical Trials
106,929 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
Ken Dornfeld, MDPrincipal InvestigatorEssentia Health Oncology

Media Library

CyberKnife (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01290835 — N/A
Breast Cancer Research Study Groups: Stereotactic radiotherapy
Breast Cancer Clinical Trial 2023: CyberKnife Highlights & Side Effects. Trial Name: NCT01290835 — N/A
CyberKnife (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01290835 — N/A
~1 spots leftby Jun 2025
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