Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT03265379

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FACT-B and Brief Pain Inventory

Study Details

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

Study ID

NCT03265379

Start date

Aug 22, 2017

Status verified date

Nov, 2025

Completion date

Aug 22, 2030

Anticipated

Primary completion date

Aug 22, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

104 participants

Anticipated

Interventions and Outcome Measures

Arms

patients with an isolated recurrence in the chest wall

distant metastatic disease is present but who undergo FTCWR

patient with primary tumor, no distant ds, failed conventional

patients refusing to undergo surgery

Interventions

FACT-B and Brief Pain Inventory

Quality of Life Questionnaires

Primary outcome measure

  • differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores [ Time Frame: from baseline to 6 month evaluation ]

Central Contacts and Locations

Central contacts

Jennifer Lister, BSc CCRP

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

Locations

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

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Jennifer Lister, BSc CCRP

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

Principal Investigator:

Shaf Keshavjee

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-03.