An observational study in Breast Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by University Health Network, Toronto · Observational
Although chest wall recurrence of breast cancer is uncommon, it represents a difficult clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer recurrence in the chest wall is controversial and is complicated by the fact that no prospective evidence exists evaluating the utility of FTCWR in prolonging survival or improving health related quality of life (HRQOL) and thus, there is a lack of evidence to guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data in a prospective fashion is thus critical in this population. Therefore, we designed a prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and short-term morbidity and mortality, with secondary focus on potential long-term overall survival benefit.
This study is a prospective, non-randomized cohort study for patients with chest wall-recurrent/invasive breast cancer treated with full thickness chest wall resection (FTCWR), chemotherapy and/or radiation. The design of this study was created using the framework for surgical trials set out by the IDEAL collaboration (Idea, Development, Exploration, Assessment, Long-Term follow up), 14 after a systematic evaluation of the current literature had been completed. Given that no prospective evidence exists in this patient population and based on the IDEAL framework, this study is designed to create a prospective registry.
Data on the efficacy of the standard interventions (surgery, chemotherapy, radiation) will be evaluated using 'global criteria', that is, the data that will be collected via the scores on the FACT-B, the Brief Pain Inventory, and the specific cancer outcomes as outlined previously (local regional recurrence (LRC), overall survival, short term morbidity and mortality as well as disease-free survival).
The primary objective is to measure the differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores from baseline to 6 month evaluation.
In addition to measuring health related quality of life (HRQOL) at 6 months, differences in the FACT-B scale at 1-month, 3-months and 1-year postoperatively will be examined. Rates of LRC, defined as local recurrence in the ipsilateral chest wall, axilla, infra- or supraclavicular region at 1, 2, 3 and 5-years postoperatively will be measured, as well as thirty and ninety-day morbidity and mortality (to be classified using the Thoracic Morbidity and Mortality (TM and M) classification system). As well, data will be collected on overall survival, measured as the proportion of patients surviving to at 1-year, 2-years, 3-years and 5 years postoperatively. Lastly, data will be collected on disease-free survival, defined as any evidence of systemic recurrence plus LRR at 1-year, 2-years, 3-years and 5-years postoperatively.
Patients with chest wall-recurrent/invasive breast cancer treated with FTCWR, chemotherapy and/or radiation.
Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue, intercostal muscle or soft-tissue) that is:
Exclusion Criteria:
Other: FACT-B and Brief Pain Inventory
Other: FACT-B and Brief Pain Inventory
Other: FACT-B and Brief Pain Inventory
Other: FACT-B and Brief Pain Inventory
Quality of Life Questionnaires
differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
Time frame: from baseline to 6 month evaluation
FACT-B scale
Time frame: 1-month, 3-months and 1-year postoperatively
Local Recurrence
Time frame: 1, 2, 3 and 5-years postoperatively
Morbidity and mortality
Time frame: 90 days post op
Overall Survival
Time frame: 1-year, 2-years, 3-years and 5 years postoperatively
Disease Free Survival
Time frame: 1-year, 2-years, 3-years and 5 years postoperatively
Brief Pain Inventory
Time frame: 1 month, 3 months, 6 months and 1 year postoperatively.
Plan to share: No
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University Health Network, Toronto