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A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy

Phase 2
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.

Outcome Time Frame:

Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)

Safety Issue:


Principal Investigator

Scott Holden, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

June 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Trastuzumab emtansine
  • MBC
  • Breast cancer
  • HER2-positive breast cancer
  • HER2
  • Breast Neoplasms



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