Breast Neoplasms
Conditions
Brief summary
Multi-center, open-label, randomized trial of patients with low-risk, HER2+ disease, who will receive adjuvant taxane-based chemotherapy (i.e. docetaxel and cyclophosphamide with trastuzumab \[TC-H\] or weekly paclitaxel with trastuzumab \[P-H\]) at the standard approved doses, aiming to gather more information regarding cost-effectiveness, toxicity, quality of life (QoL), patient reported outcomes and clinical benefits of the two treatment strategies.
Detailed description
Multi-center, open-label, randomized trial of patients with low-risk, HER2+ disease, who will receive adjuvant taxane-based chemotherapy (i.e. docetaxel and cyclophosphamide with trastuzumab \[TC-H\] or weekly paclitaxel with trastuzumab \[P-H\]) at the standard approved doses. The primary objective is to estimate the feasibility of opening a pragmatic clinical trial with an Integrated Consent Model Secondary objectives are: Compare adverse events/ toxicity profile between the two different approaches (i.e. neutropenia, peripheral neuropathy, treatment-related hospitalizations, proportion of patients completing the chemotherapy component of their treatment); Estimate the cost of each chemotherapy regimen and potential cost-effectiveness analysis from the perspective of Canada's health care system; Evaluate the impact on activities of daily living as reflected by self-reported fatigue and pain using the FACT-Taxane and FACIT-Fatigue scores. In this study, the investigator will obtain oral consent using the prepared REB approved Consent Script. If the patient agrees to participate, the physician will dictate in the progress note they have had the above conversation with the patient. There will be no need for the patient to sign an informed consent form.
Interventions
DRUGTC-H x Paclitaxel (P) + Trastuzumab(T)
chemotherapy
Sponsors
The Ottawa Hospital
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with HER-2 positive early stage breast cancer for whom TC-H or weekly P-H is being considered. * Able to provide verbal consent. * Willing to complete study related-questionnaires
Exclusion criteria
* Unable to give informed consent or complete questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of performing a pragmatic clinical trial with an Integrated Consent Model. | up to 12 months. | Feasibility of performing this study will be measured with 2 composite endpoints: number of patients who received either TC-H or P-H chemotherapy compared to the number of participants who were approached to enter the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events/ toxicity profile between the two different approaches. | up to 12 months. | Toxicity profile (NCI CTC version 4.1) |
| Cost of each chemotherapy regimen and potential cost-effectiveness analysis. | up to 12 months. | Health system cost of each chemotherapy regimen. |
| Cost-effectiveness analysis. | up to 12 months. | Cost per one quality-adjusted life year (QALY) gained. |
| Quality of life as reflected by self-reported fatigue using FACIT-Fatigue scores. | up to 12 months. | Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) scores |
| Quality of life as reflected by self-reported pain using FACT-Taxane scores | up to 12 motnhs. | Functional Assessment of Cancer Therapy-Taxane Scores. |
Countries
Canada
Outcome results
None listed