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

NCT03705429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-08-19

No results posted yet for this study

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

Interventions

DRUG

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

chemotherapy

Sponsors & Collaborators

  • The Ottawa Hospital

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Ricardo Fernandes, M.D. · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-05-11
Completion
2022-05-11

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705429 on ClinicalTrials.gov