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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705429
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: TC-H x Paclitaxel (P) + Trastuzumab(T) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Multi-Centre Randomized Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 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.
Drug: TC-H x Paclitaxel (P) + Trastuzumab(T)
chemotherapy
Other Names:
  • Docetaxel, Cyclophosphamide and Trastuzumab
  • Paclitaxel and Trastuzumab

Placebo Comparator: 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.
Drug: TC-H x Paclitaxel (P) + Trastuzumab(T)
chemotherapy
Other Names:
  • Docetaxel, Cyclophosphamide and Trastuzumab
  • Paclitaxel and Trastuzumab




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Adverse events/ toxicity profile between the two different approaches. [ Time Frame: up to 12 months. ]
    Toxicity profile (NCI CTC version 4.1)

  2. Cost of each chemotherapy regimen and potential cost-effectiveness analysis. [ Time Frame: up to 12 months. ]
    Health system cost of each chemotherapy regimen.

  3. Cost-effectiveness analysis. [ Time Frame: up to 12 months. ]
    Cost per one quality-adjusted life year (QALY) gained.

  4. Cost-effectiveness analysis. [ Time Frame: up to 12 months. ]
    Use of primary or secondary febrile neutropenia prophylaxis.

  5. Quality of life as reflected by self-reported fatigue using FACIT-Fatigue scores. [ Time Frame: up to 12 months. ]
    Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) scores

  6. Quality of life as reflected by self-reported pain using FACT-Taxane scores [ Time Frame: up to 12 motnhs. ]
    Functional Assessment of Cancer Therapy-Taxane Scores.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03705429


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Sponsors and Collaborators
Lawson Health Research Institute
The Ottawa Hospital
Investigators
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Principal Investigator: Ricardo Fernandes, M.D. Lawson Health Research Institute
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03705429    
Other Study ID Numbers: REaCT-Low Risk HER-2
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological