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 | Recruiting

• 1 other identifier: 17-5560
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores

  from baseline to 6 month evaluation

Secondary Outcomes (6)

• 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

Study Arms (4)

patients with an isolated recurrence in the chest wall

Other: FACT-B and Brief Pain Inventory

distant metastatic disease is present but who undergo FTCWR

Other: FACT-B and Brief Pain Inventory

patient with primary tumor, no distant ds, failed conventional

Other: FACT-B and Brief Pain Inventory

patients refusing to undergo surgery

Other: FACT-B and Brief Pain Inventory

Interventions

FACT-B and Brief Pain Inventory OTHER

Quality of Life Questionnaires

distant metastatic disease is present but who undergo FTCWR; patient with primary tumor, no distant ds, failed conventional; patients refusing to undergo surgery; patients with an isolated recurrence in the chest wall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>18 years of age
• Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue, intercostal muscle or soft-tissue) that is:
• Radiologically proven on cross-sectional imaging
• Histologically proven
• Medically fit for surgery
• \>1 year disease-free interval (between initial treatment and recurrence) for patients with local recurrence

You may not qualify if:

• Medically inoperable due to co-morbidity or other contraindication to surgery
• Technically unresectable disease
• Ineligible for chemotherapy
• ECOG performance status \>2
• Patient refusal

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre)

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shaf Keshavjee

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lister, BSc CCRP

CONTACT

416-340-4857; Jennifer.Lister@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: August 22, 2017
• Primary Completion (Estimated): August 22, 2030
• Study Completion (Estimated): August 22, 2030
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)