Breast CancerNCT03265379
Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection
An observational study of Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FACT-B and Brief Pain Inventory
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2017to 22 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chest wall-recurrent/invasive breast cancer treated with FTCWR, chemotherapy and/or radiation.
Who may be able to join
- >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
Who cannot join
- Medically inoperable due to co-morbidity or other contraindication to surgery
- Technically unresectable disease
- Ineligible for chemotherapy
- ECOG performance status >2
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre)
Toronto, Ontario, M5G 2C4
Jennifer Lister, BSc CCRP, 416-340-4857, Jennifer.Lister@uhn.ca
Shaf Keshavjee
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- FACT-B and Brief Pain Inventory
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACT-B and Brief Pain InventoryOther
Quality of Life Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| patients with an isolated recurrence in the chest wall | Not described Receives: Other: FACT-B and Brief Pain Inventory | |
| distant metastatic disease is present but who undergo FTCWR | Not described Receives: Other: FACT-B and Brief Pain Inventory | |
| patient with primary tumor, no distant ds, failed conventional | Not described Receives: Other: FACT-B and Brief Pain Inventory | |
| patients refusing to undergo surgery | Not described Receives: Other: FACT-B and Brief Pain Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
Measured: from baseline to 6 month evaluation
Secondary outcomes (6)
FACT-B scale
Measured: 1-month, 3-months and 1-year postoperatively
Local Recurrence
Measured: 1, 2, 3 and 5-years postoperatively
Morbidity and mortality
Measured: 90 days post op
Overall Survival
Measured: 1-year, 2-years, 3-years and 5 years postoperatively
Disease Free Survival
Measured: 1-year, 2-years, 3-years and 5 years postoperatively
Brief Pain Inventory
Measured: 1 month, 3 months, 6 months and 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start22 Aug 2017
- Primary completion22 Aug 2030 (estimated)
- Study completion22 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaf Keshavjee, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265379
- Sponsor's protocol ID
- 17-5560
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2017
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection
- ClinicalTrials.gov ID
- NCT03265379
- Acronym / sponsor ID
- 17-5560
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 22 Aug 2030 (estimated)
- Study completion
- 22 Aug 2030 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest wall-recurrent/invasive breast cancer treated with FTCWR, chemotherapy and/or radiation.
Key inclusion criteria (6 listed)
- >18 years of age
- Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue, intercostal muscle or soft-tissue) that is:
- Medically fit for surgery
- >1 year disease-free interval (between initial treatment and recurrence) for patients with local recurrence
Key exclusion criteria (5 listed)
- Medically inoperable due to co-morbidity or other contraindication to surgery
- Technically unresectable disease
- Ineligible for chemotherapy
- ECOG performance status >2
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACT-B and Brief Pain InventoryQuality of Life Questionnaires | Other | 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 |
Primary outcome
differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
Time frame: from baseline to 6 month evaluation
6 secondary outcomes
FACT-B scale
Time frame: 1-month, 3-months and 1-year postoperatively
Local Recurrence
Time frame: 1, 2, 3 and 5-years postoperatively
Morbidity and mortality
Time frame: 90 days post op
Overall Survival
Time frame: 1-year, 2-years, 3-years and 5 years postoperatively
Disease Free Survival
Time frame: 1-year, 2-years, 3-years and 5 years postoperatively
Brief Pain Inventory
Time frame: 1 month, 3 months, 6 months and 1 year postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaf Keshavjee principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Lister, BSc CCRP (416-340-4857, Jennifer.Lister@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores (time frame: from baseline to 6 month evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.