Registry for Patients with Breast Cancer Invading the Chest Wall Undergoing Surgery
Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection
This study is testing how well surgery to remove breast cancer that has spread to the chest wall works for patients and how it affects their quality of life and survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03265379 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the outcomes of full thickness chest wall resection (FTCWR) in patients with chest wall-recurrent breast cancer. It will collect data on health-related quality of life (HRQOL), local-regional recurrence (LRC), and survival rates through a prospective registry. Patients will be assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B) scale and the Brief Pain Inventory at multiple time points post-surgery. The study follows the IDEAL framework to ensure comprehensive evaluation and data collection.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with histologically and radiologically proven breast cancer invading the chest wall who are medically fit for surgery.
Not a fit: Patients who are medically inoperable, have technically unresectable disease, or have a poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving the quality of life and treatment outcomes for patients with chest wall-recurrent breast cancer.
How similar studies have performed: While there is limited prospective evidence specifically for FTCWR in this context, the study's approach aligns with established frameworks for surgical trials, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre) — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Shaf Keshavjee — University Health Network, Toronto
- Study coordinator: Jennifer Lister, BSc CCRP
- Email: Jennifer.Lister@uhn.ca
- Phone: 416-340-4857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.