Phase 2
Completed N=112
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00509769 ↗Enrolled (actual)
112
Serious AEs
26.8%
Results posted
Apr 2013
Primary outcomePrimary: Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) — 25.7; 26.9 Percentage of patients
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) |
25.7; 26.9 | — |
| SECONDARY Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) |
NA | — |
| SECONDARY Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) |
4.6 | — |
| SECONDARY Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) |
38.9 | — |
| SECONDARY Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) |
9.4 | — |
| SECONDARY Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) |
4.6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00509769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.