Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03265379
• Other study ID #: 17-5560
• Status: Recruiting
• Start date: August 22, 2017
• Est. completion date: August 22, 2030

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Jennifer Lister, BSc CCRP
• Phone: 416-340-4857
• Email: Jennifer.Lister[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: August 22, 2030
• Est. primary completion date: August 22, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. >18 years of age

2. Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue, intercostal muscle or soft-tissue) that is:

1. Radiologically proven on cross-sectional imaging

2. Histologically proven

3. Medically fit for surgery

4. >1 year disease-free interval (between initial treatment and recurrence) for patients with local recurrence

Exclusion Criteria:

1. Medically inoperable due to co-morbidity or other contraindication to surgery

2. Technically unresectable disease

3. Ineligible for chemotherapy

4. ECOG performance status >2

5. Patient refusal

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• FACT-B and Brief Pain Inventory
Quality of Life Questionnaires

Locations

Country	Name	City	State
Canada	University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores		from baseline to 6 month evaluation
Secondary	FACT-B scale		1-month, 3-months and 1-year postoperatively
Secondary	Local Recurrence		1, 2, 3 and 5-years postoperatively
Secondary	Morbidity and mortality		90 days post op
Secondary	Overall Survival		1-year, 2-years, 3-years and 5 years postoperatively
Secondary	Disease Free Survival		1-year, 2-years, 3-years and 5 years postoperatively
Secondary	Brief Pain Inventory		1 month, 3 months, 6 months and 1 year postoperatively.