Single Fraction Preoperative Radiation as a Strategy for Local Control of Breast Cancer During a COVID-19 Pandemic
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Lawson Health Research Institute
- Primary Endpoint
- Feasibility of SBRT during a pandemic
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female sex
- •Age ≥ 50 years old
- •Postmenopausal
- •Tumor size \< 3cm on pre-treatment imaging
- •Any grade of disease, estrogen receptor (ER) positive, HER2 negative
- •Unicentric/unifocal disease
- •Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
- •Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
- •Surgical expectation that a \> 2mm margin can be obtained.
- •Lesion is 1 cm or greater from the skin surface.
Exclusion Criteria
- •Under 50 years of age
- •Previous RT to the same breast
- •HER2 positive disease
- •Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
- •Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
- •Distant metastases
- •Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
- •Prior non-hormonal therapy or radiation therapy for the current breast cancer
- •Patients with Paget's disease of the nipple.
- •Skin involvement, regardless of tumor size.
Outcomes
Primary Outcomes
Feasibility of SBRT during a pandemic
Time Frame: 1 year
To demonstrate feasibility of treating early stage breast cancer patients with a single 21 Gy fraction during the COVID-19 pandemic. This will be measured by accrual rate and the number of patients that can be treated during this pandemic.
Pathologic complete response (pCR)
Time Frame: 1 year
To evaluate whether a pathologic complete response can be achieved when radiotherapy is delivered in a single 21 Gy fraction, establishing whether tumour response has a linear function with time in the context of delayed surgery. Pathologic complete response will be treated as a dichotomous variable (yes/no). Results will be stratified based on whether patients were also placed on neoadjuvant hormone treatment.
Secondary Outcomes
- Radiation toxicity(1.5 years)
- Cosmesis(1.5 years)