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

NCT03265379 · tracked via the Priya Life Science Canada tracker

Sponsor

University Health Network, Toronto

Phase

Observational

Started

2017-08-22

Last updated

2025-12-03

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

FACT-B and Brief Pain Inventory

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre)	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03265379 on ClinicalTrials.gov ↗ ← All trials in Canada