Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.

Study Overview

• Status: Completed
• Conditions: Early Stage Breast Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• DCIS or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologies.
• Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 or T2 (≤3 cm) treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy. Patients with up to 3 positive nodes without microscopic or macroscopic evidence of extracapsular extension are eligible.
• The patient's Zubrod performance status must be 0-2.
• Patients must be ≥ 18 years of age.
• If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation therapy.
• Unifocal breast cancer (no evidence of gross multifocal disease, multicentric, or bilateral disease.
• Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as >2 mm clear of tumor in all directions).
• Negative post- lumpectomy mammography if malignancy-associated microcalcifications were initially present.
• The target lumpectomy cavity must be clearly delineated.
• Patients must complete appropriate pretreatment evaluation, including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal.

Exclusion Criteria:

• Evidence of suspicious microcalcifications in the breast prior to start of radiation.
• Patients with history of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
• Patients with 4 or more histologically positive axillary nodes if axillary dissection is performed.
• Patients with distant metastases.
• Patients with invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma.
• Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy.
• Patients must not have any palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
• Any previously treated contralateral invasive breast carcinoma or synchronous contralateral breast carcinoma.
• Prior non-hormonal therapy or radiation therapy for the current breast cancer or hormonal therapy for > 28 days after diagnosis or refusal to discontinue hormonal therapy.
• Patients with Paget's disease of the nipple
• Patients with prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
• Patients with severe, active co-morbidity.
• Patients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consent.
• Patients who are pregnant or lactating.
• Previous breast radiation on either side or thoracic radiation on the ipsilateral side..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stereotactic Body Radiation Therapy; SBRT dose per fraction	Radiation: Stereotactic Body Radiation Therapy; 3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation).; Other Names: SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum tolerated dose to the lumpectomy cavity in patients with early stage breast cancer	To escalate the dose of stereotactic radiotherapy utilizing the Cyberknife system to a tumorcidal dose to the lumpectomy cavity without exceeding the maximum tolerated dose in patients with early stage breast cancer.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicity	3 years
The cosmesis of breast	3 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Asal Rahimi, MD, UT Southwestern Medical Center Dallas

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2010
• Primary Completion (Actual): July 25, 2015
• Study Completion (Actual): December 28, 2015

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STU 072010-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO