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NCT03705429

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

Completed Phase 3 Last updated 19 August 2022
What this trial tests

Phase 3 trial testing TC-H x Paclitaxel (P) + Trastuzumab(T) in Breast Neoplasms in 51 participants. Completed in 11 May 2022.

Timeline
1 May 2019
Primary endpoint
11 May 2022
11 May 2022

Quick facts

Lead sponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment51
Start date1 May 2019
Primary completion11 May 2022
Estimated completion11 May 2022
Sites3 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

18 and older, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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, aiming to gather more information regarding cost-effectiveness, toxicity, quality of life (QoL), patient reported outcomes and clinical benefits of the two treatment strategies.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evolving Role of Risk Tailored Therapy in Early Stage HER2-Positive Breast Cancer: A Canadian Perspective.
    McGee SF, Clemons M, Savard MF. · · 2022 · cited 2× · PMID 35735438 · DOI 10.3390/curroncol29060329
  2. The Rethinking Clinical Trials (REaCT) Program: A Pragmatic Research Strategy to Improve Cancer Care for Patients, Caregivers, and Healthcare Systems.
    Savard MF, Clemons M, McGee SF. · · 2025 · cited 1× · PMID 41002554 · DOI 10.3390/curroncol32090484

Verify or expand the search:

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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