A Multi-Centre Randomized Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 51
- Locations
- 3
- Primary Endpoint
- Feasibility of performing a pragmatic clinical trial with an Integrated Consent Model.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
TC-H Chemotherapy
Docetaxel 75 mg/m2, Cyclophosphamide 600 mg/m2 and Trastuzumab 8 mg/kg followed by 6 mg/kg Day 1 every 21 days for 4 cycles. Trastuzumab 6 mg/kg Day 1 every 21 days to complete 1 year of Trastuzumab therapy.
Intervention: TC-H x Paclitaxel (P) + Trastuzumab(T) (Drug)
Paclitaxel(P) + Trastuzumab(T)
Paclitaxel 80 mg/m2 weekly for 12 weeks and Trastuzumab 8 mg/kg followed by 6 mg/kg Day 1 every 21 days for 4 cycles. Trastuzumab 6 mg/kg Day 1 every 21 days to complete 1 year of Trastuzumab therapy. Alternatively Trastuzumab 4 mg/kg followed by 2 mg/kg weekly to complete 1 year of treatment can be used.
Intervention: TC-H x Paclitaxel (P) + Trastuzumab(T) (Drug)
Outcomes
Primary Outcomes
Feasibility of performing a pragmatic clinical trial with an Integrated Consent Model.
Time Frame: 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 Outcomes
- Adverse events/ toxicity profile between the two different approaches.(up to 12 months.)
- Cost of each chemotherapy regimen and potential cost-effectiveness analysis.(up to 12 months.)
- Cost-effectiveness analysis.(up to 12 months.)
- Quality of life as reflected by self-reported fatigue using FACIT-Fatigue scores.(up to 12 months.)
- Quality of life as reflected by self-reported pain using FACT-Taxane scores(up to 12 motnhs.)