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

Breast Neoplasms Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT03705429
• Other study ID #: REaCT-Low Risk HER-2
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: May 11, 2022

Study information

• Verified date: August 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• TC-H x Paclitaxel (P) + Trastuzumab(T)
chemotherapy

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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