Regulatory approval

Published by the Health Canada. Approved

Health Canada approved trastuzumab in combination with paclitaxel or docetaxel for the treatment of early stage breast cancer patients with ECOG 0-1 status, whose tumors overexpress HER2, following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide.

This is written in the approval document as:

HERCEPTIN (trastuzumab for injection) is indicated for the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours overexpress HER2, following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.

Citation

Hoffmann-La Roche Limited. Herceptin (trastuzumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080472.PDF. Revised May 2025. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Paclitaxel, Trastuzumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals