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

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ClinicalTrials.gov Identifier: NCT03265379
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Breast Cancer Other: FACT-B and Brief Pain Inventory

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 Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : August 22, 2022
Estimated Study Completion Date : August 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
patients with an isolated recurrence in the chest wall Other: FACT-B and Brief Pain Inventory
Quality of Life Questionnaires

distant metastatic disease is present but who undergo FTCWR Other: FACT-B and Brief Pain Inventory
Quality of Life Questionnaires

patient with primary tumor, no distant ds, failed conventional Other: FACT-B and Brief Pain Inventory
Quality of Life Questionnaires

patients refusing to undergo surgery Other: FACT-B and Brief Pain Inventory
Quality of Life Questionnaires




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

Secondary Outcome Measures :
  1. FACT-B scale [ Time Frame: 1-month, 3-months and 1-year postoperatively ]
  2. Local Recurrence [ Time Frame: 1, 2, 3 and 5-years postoperatively ]
  3. Morbidity and mortality [ Time Frame: 90 days post op ]
  4. Overall Survival [ Time Frame: 1-year, 2-years, 3-years and 5 years postoperatively ]
  5. Disease Free Survival [ Time Frame: 1-year, 2-years, 3-years and 5 years postoperatively ]
  6. Brief Pain Inventory [ Time Frame: 1 month, 3 months, 6 months and 1 year postoperatively. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chest wall-recurrent/invasive breast cancer treated with FTCWR, chemotherapy and/or radiation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265379


Contacts
Contact: Jennifer Lister, BSc CCRP 416-340-4857 Jennifer.Lister@uhn.ca

Locations
Canada, Ontario
University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre) Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jennifer Lister, BSc CCRP    416-340-4857    Jennifer.Lister@uhn.ca   
Principal Investigator: Shaf Keshavjee         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Shaf Keshavjee University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03265379     History of Changes
Other Study ID Numbers: 17-5560
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases