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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: FACT-B and Brief Pain Inventory

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 104

Contacts and Locations

• Study Contact: Name: Jennifer Lister, BSc CCRP; Phone Number: 416-340-4857; Email: Jennifer.Lister@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre)
      • Contact: Jennifer Lister, BSc CCRP; Phone Number: 416-340-4857; Email: Jennifer.Lister@uhn.ca
      • Principal Investigator: Shaf Keshavjee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chest wall-recurrent/invasive breast cancer treated with FTCWR, chemotherapy and/or radiation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with an isolated recurrence in the chest wall	Other: FACT-B and Brief Pain Inventory; Quality of Life Questionnaires
distant metastatic disease is present but who undergo FTCWR	Other: FACT-B and Brief Pain Inventory; Quality of Life Questionnaires
patient with primary tumor, no distant ds, failed conventional	Other: FACT-B and Brief Pain Inventory; Quality of Life Questionnaires
patients refusing to undergo surgery	Other: FACT-B and Brief Pain Inventory; Quality of Life Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores	from baseline to 6 month evaluation

Secondary Outcome Measures

Outcome Measure	Time Frame
FACT-B scale	1-month, 3-months and 1-year postoperatively
Local Recurrence	1, 2, 3 and 5-years postoperatively
Morbidity and mortality	90 days post op
Overall Survival	1-year, 2-years, 3-years and 5 years postoperatively
Disease Free Survival	1-year, 2-years, 3-years and 5 years postoperatively
Brief Pain Inventory	1 month, 3 months, 6 months and 1 year postoperatively.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Shaf Keshavjee, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Anticipated): August 22, 2030
• Study Completion (Anticipated): August 22, 2030

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 17-5560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No