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.
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
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
Name | Type | Description | Interventions |
---|
Stereotactic body radiotherapy (SBRT) | Experimental | Radiotherapy 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: | Unknown status |
Lead Sponsor: | Juravinski Cancer Center |
Trial Keywords
- Feasibility study
- Early breast cancer
- Stereotactic body radiotherapy
- Cyberknife
- Pre-operative radiotherapy
Last Updated
March 31, 2015