Clinical Trials /

Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer

NCT02065960

Description:

Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer. Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response. If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer
  • Official Title: Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 13-699
  • NCT ID: NCT02065960

Conditions

  • Breast Neoplasm

Purpose

Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer. Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response. If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.

Trial Arms

NameTypeDescriptionInterventions
Stereotactic body radiotherapy (SBRT)ExperimentalRadiotherapy with SBRT to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10-12 days, followed by breast conserving surgery.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Women age ≥ 70 years;
    
              -  New histological diagnosis of invasive carcinoma of the breast, grade I or II,
                 estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle
                 biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with
                 MRI of the breasts and axillary ultrasound;
    
              -  Candidate for breast conserving surgery;
    
              -  Signed study consent form completed prior to study entry.
    
            Exclusion Criteria:
    
              -  Breast cancer with disease within 5 mm from skin or chest wall;
    
              -  Previous or concomitant invasive malignancies treated within 5 years of study entry;
    
              -  Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or
                 scleroderma), which would preclude to definitive radiation therapy;
    
              -  Psychiatric disorders, which would preclude from obtaining informed consent
    
              -  Geographic inaccessibility for follow-up
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:70 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Feasibility
    Time Frame:At time of radiation treatment delivery
    Safety Issue:
    Description:The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.

    Secondary Outcome Measures

    Measure:Acute Radiation Toxicity
    Time Frame:Within 3 months from radiation
    Safety Issue:
    Description:
    Measure:Late Radiation Toxicity
    Time Frame:3 months or more after radiation
    Safety Issue:
    Description:
    Measure:Pathological Response
    Time Frame:At time of surgery (10-12 weeks post-radiation)
    Safety Issue:
    Description:
    Measure:Ipsilateral Breast Tumour Recurrence
    Time Frame:At 5 years post-registration
    Safety Issue:
    Description:
    Measure:Disease Free Survival
    Time Frame:At 5 years post-registration
    Safety Issue:
    Description:

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Juravinski Cancer Center

    Trial Keywords

    • Feasibility study
    • Early breast cancer
    • Stereotactic body radiotherapy
    • Cyberknife
    • Pre-operative radiotherapy

    Last Updated