A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Genentech

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Trastuzumab emtansine [Kadcyla]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509769

TDM4258g

Details and patient eligibility

About

This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Enrollment: 112 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form.
• Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation.
• History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer.
• At least 1, and no more than 3, chemotherapy regimens for MBC.
• Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
• Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN).
• Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion criteria

• Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.
• Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.
• History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Trastuzumab emtansine 3.6 mg/kg

Experimental group

Description:

Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.

Treatment:

Drug: Trastuzumab emtansine [Kadcyla]