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


Phase 1/Phase 2
60 Years
60 Years
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

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


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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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 treatedwhile also respecting normal tissue tolerances.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Ken Dornfeld, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Essentia Health Oncology

Authority:

United States: Food and Drug Administration

Study ID:

SMDC10101

NCT ID:

NCT01290835

Start Date:

June 2010

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Stereotactic radiotherapy
  • CyberKnife following lumpectomy
  • Breast cancer
  • Breast Neoplasms

Name

Location
Essentia Health SMDC Cancer Center Duluth, Minnesota  55805