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

NCT03705429 | Completed Phase 3 DMC

• 1 other identifier: REaCT-Low Risk HER-2
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adverse events/ toxicity profile between the two different approaches.

  up to 12 months.

• Cost of each chemotherapy regimen and potential cost-effectiveness analysis.

  up to 12 months.

• Cost-effectiveness analysis.

  up to 12 months.

• Cost-effectiveness analysis.

  up to 12 months.

• Quality of life as reflected by self-reported fatigue using FACIT-Fatigue scores.

  up to 12 months.

Study Arms (2)

TC-H Chemotherapy

ACTIVE COMPARATOR

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)

Paclitaxel(P) + Trastuzumab(T)

PLACEBO COMPARATOR

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)

Interventions

TC-H x Paclitaxel (P) + Trastuzumab(T) DRUG

chemotherapy

Also known as: Docetaxel, Cyclophosphamide and Trastuzumab, Paclitaxel and Trastuzumab

Paclitaxel(P) + Trastuzumab(T); TC-H Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent or complete questionnaires

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Ottawa Hospital: collaborator

Study Sites (3)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; Trastuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ricardo Fernandes, M.D.

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 15, 2018
• Study Start: May 1, 2019
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)