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

Recruiting in Palo Alto (17 mi)

Overseen byKen Dornfeld, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Essentia Health

Stay on Your Current Meds

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

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.

Inclusion Criteria

My cancer surgery removed all visible cancer with a clear margin of at least 2mm.

The trial is only open to individuals with cancer that is located in one specific area of the body.

My cancer is estrogen receptor positive.

+7 more

Exclusion Criteria

My breast cancer has a significant intraductal component.

My cancer is present in multiple locations within the same organ.

My cancer has spread to nearby lymph nodes.

+3 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Stereotactic radiotherapyExperimental Treatment2 Interventions

Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.

CyberKnife is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as CyberKnife Radiosurgery for: