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

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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).

Key facts

Study ID

NCT00509769

Run by

Genentech, Inc.

People needed

112

Starts

2007-07-01

Expected to finish

2009-06-01

Last updated by the study team

2013-04-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Little Rock Hem Onc Assoc — Little Rock, Arkansas, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Lynn Cancer Institute - West — Boca Raton, Florida, United States
• Florida Cancer Care — Davie, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Hem/Onc Assoc - Treasure Coast — Port Saint Lucie, Florida, United States
• Gulfcoast Oncology Associates — St. Petersburg, Florida, United States
• Bay Area Oncology — Tampa, Florida, United States
• Northwest Georgia Onc Ctrs PC — Marietta, Georgia, United States
• John McClean, M.D. - Private P — Galesburg, Illinois, United States
• Cedar Valley Med Specialists — Waterloo, Iowa, United States
• Kentuckiana Cancer Institute — Louisville, Kentucky, United States
• Minnesota Oncology Hematology, — Minneapolis, Minnesota, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• Kansas City Cancer Center, LLC — Lee's Summit, Missouri, United States
• St. Louis Cancer & Breast Inst — St Louis, Missouri, United States
• St. Barnabas Health Care Sys — Livingston, New Jersey, United States
• New York Oncology Hematology — Albany, New York, United States
• Eastchester Center/Cancer Care — The Bronx, New York, United States
• Carolinas Hem-Oncology Assoc — Charlotte, North Carolina, United States
• Raleigh Hemotology & Oncology — Raleigh, North Carolina, United States
• Midwestern Regional Med Center — Eugene, Oregon, United States
• Texas Oncology Cancer Center — Austin, Texas, United States
• Texas Oncology, P.A. — Bedford, Texas, United States

Full record on ClinicalTrials.gov

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