Abstract
Background
Breast-conserving therapy has become a preferred option in the treatment of early breast cancer. Current breast-conserving therapy includes 3–5 weeks of external beam radiotherapy to the whole breast, sometimes followed by a 1–2-week boost to the tumor bed. However, the duration of the radiation regimen can be prohibitive for the elderly, infirm or immobile patients, those patients who live far from the cancer center, or those who have difficulty taking an extended leave of absence. We propose to treat these patients with a single dose of radiation preoperatively, thereby shortening the total treatment time.
Methods
This is a single-arm phase II case series trial, conducted on 120 patients with early breast cancer who will be accrued from multidisciplinary breast cancer clinics. These patients will have research biopsies taken at the time of enrollment and will undergo radiation planning with CT simulation and PET/MRI. A single dose of 21 Gy will then be delivered in the prone position to the tumor. A second research biopsy will be taken, then lumpectomy will be performed. This entire procedure will be completed within 1 week (7 days). The primary endpoint is rate of toxicity (≥grade 2 fibrosis), and secondary endpoints include cosmetic results, quality of life, and rate of recurrence.
Discussion
This study will assess the toxicity associated with using a single preoperative dose of radiation as a replacement for standard adjuvant radiotherapy in breast-conserving therapy. Results of this trial will guide the design of a possible phase III study.
Trial registration: Clinicaltrials.gov identifier: NCT02212860
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All human and animal studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All persons gave their informed consent prior to their inclusion in the study. This trial protocol has been reviewed and approved by the Western University Human Subjects Research Ethics Board (study #105643). Protocol modifications recommended by the DSMC will be communicated directly to the Principal Investigator, the co-investigators, and the Office of Research Ethics within 24 h. Informed consent will be obtained from patients before enrollment in the study, by the care-providing surgeon at the time of surgical consult and confirmation of eligibility. All patients will be made aware of the standard treatment, which includes external beam radiotherapy (50 Gy/25 fractions). All confidential information collected throughout the duration of the study will be stored in a firewall-protected file. Access will be permitted to the investigators listed and the DSMC.
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The authors declare that they have no competing interests.
Funding sources
Lawson Internal Research Fund, Lawson Health Research Institute, London, Canada—$15,000. Ontario Research Fund—$30,000.
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Guidolin, K., Lock, M., Yaremko, B. et al. A phase II trial to evaluate single-dose stereotactic body radiation therapy (SBRT) prior to surgery for early-stage breast carcinoma: SIGNAL (stereotactic image-guided neoadjuvant ablative radiation then lumpectomy) trial. J Radiat Oncol 4, 423–430 (2015). https://doi.org/10.1007/s13566-015-0227-2
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DOI: https://doi.org/10.1007/s13566-015-0227-2