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A Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer

NCT03705429

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, aiming to gather more information regarding cost-effectiveness, toxicity, quality of life (QoL), patient reported outcomes and clinical benefits of the two treatment strategies.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: REaCT-Low Risk HER-2
  • NCT ID: NCT03705429

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
TC-H x Paclitaxel (P) + Trastuzumab(T)Docetaxel, Cyclophosphamide and Trastuzumab, Paclitaxel and TrastuzumabTC-H Chemotherapy

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
TC-H ChemotherapyActive ComparatorDocetaxel 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.
  • TC-H x Paclitaxel (P) + Trastuzumab(T)
Paclitaxel(P) + Trastuzumab(T)Placebo ComparatorPaclitaxel 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.
  • TC-H x Paclitaxel (P) + Trastuzumab(T)

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Feasibility of performing a pragmatic clinical trial with an Integrated Consent Model.
Time Frame:up to 12 months.
Safety Issue:
Description: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 Outcome Measures

Measure:Adverse events/ toxicity profile between the two different approaches.
Time Frame:up to 12 months.
Safety Issue:
Description:Toxicity profile (NCI CTC version 4.1)
Measure:Cost of each chemotherapy regimen and potential cost-effectiveness analysis.
Time Frame:up to 12 months.
Safety Issue:
Description:Health system cost of each chemotherapy regimen.
Measure:Cost-effectiveness analysis.
Time Frame:up to 12 months.
Safety Issue:
Description:Cost per one quality-adjusted life year (QALY) gained.
Measure:Cost-effectiveness analysis.
Time Frame:up to 12 months.
Safety Issue:
Description:Use of primary or secondary febrile neutropenia prophylaxis.
Measure:Quality of life as reflected by self-reported fatigue using FACIT-Fatigue scores.
Time Frame:up to 12 months.
Safety Issue:
Description:Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) scores
Measure:Quality of life as reflected by self-reported pain using FACT-Taxane scores
Time Frame:up to 12 motnhs.
Safety Issue:
Description:Functional Assessment of Cancer Therapy-Taxane Scores.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:London Health Sciences Centre

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