Clinical trial NCT03705429: A Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
Official title: A Multi-Centre Randomized Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2018-10-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of performing a pragmatic clinical trial with an Integrated Consent Model.
timeFrame: up to 12 months.
Secondary outcomes:
measure: Adverse events/ toxicity profile between the two different approaches.
timeFrame: up to 12 months.
measure: Cost of each chemotherapy regimen and potential cost-effectiveness analysis.
timeFrame: up to 12 months.
measure: Cost-effectiveness analysis.
timeFrame: up to 12 months.
measure: Cost-effectiveness analysis.
timeFrame: up to 12 months.
measure: Quality of life as reflected by self-reported fatigue using FACIT-Fatigue scores.
timeFrame: up to 12 months.
measure: Quality of life as reflected by self-reported pain using FACT-Taxane scores
timeFrame: up to 12 motnhs.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ricardo Fernandes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: