Official Title
Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection
Summary:
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.
Trial Description
Primary Outcome:
- differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
Secondary Outcome:
- FACT-B scale
- Local Recurrence
- Morbidity and mortality
- Overall Survival
- Disease Free Survival
- Brief Pain Inventory
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.
View this trial on ClinicalTrials.gov
