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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03705429

Collaborator

The Ottawa Hospital (Other)

Enrollment

Locations

Arms

36.3

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Study Design

Study Type:

Interventional

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

Actual Primary Completion Date :

May 11, 2022

Actual Study Completion Date :

May 11, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Feasibility of performing a pragmatic clinical trial with an Integrated Consent Model. [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre	London	Ontario	Canada	N6A5W9
2	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
3	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada	P7B 6V4