Herceptin (trastuzumab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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 surgery and after chemotherapy. 1
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. 1
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, in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. 1
HERCEPTIN (trastuzumab for injection) is indicated for the treatment of patients with metastatic breast cancer (MBC) whose tumours overexpress HER2. 1
HERCEPTIN (trastuzumab for injection) can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. 1
HERCEPTIN (trastuzumab for injection) in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Trastuzumab
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Docetaxel, Paclitaxel, Trastuzumab
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Carboplatin, Docetaxel, Trastuzumab
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Trastuzumab
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Docetaxel, Pertuzumab, Trastuzumab