A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Ado-Trastuzumab Emtansine; Maytansine; Trastuzumab

Criteria

Inclusion Criteria:

• Signed study-specific Informed Consent Form(s)

• Age ≥ 18 years

• Histologically documented breast cancer

• HER2-positive disease

• Metastatic breast cancer

• Disease progression on the last chemotherapy regimen received in the metastatic setting

• Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or metastatic setting and prior treatment with at least two lines of therapy (a line of therapy can be a combination of two agents or single-agent chemotherapy) in the metastatic setting

• At least two lines of anti-HER2 therapy must have been given in the metastatic setting as monotherapy or combined with chemotherapy or hormonal therapy. The HER2-targeted agent can include trastuzumab, lapatinib, or an investigational agent with HER2-inhibitory activity.

• A minimum of 6 weeks of trastuzumab for the treatment of metastatic disease is required

• Patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine

Exclusion Criteria:

• Chemotherapy ≤ 21 days before enrollment

• Trastuzumab ≤ 21 days before enrollment

• Hormone therapy ≤ 7 days before enrollment

• Granulocyte-stimulating agent < 14 days before enrollment

• Investigational therapy ≤ 28 days before enrollment

• Previous radiotherapy for treatment of metastatic breast cancer ≤ 21 days before enrollment

• Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 3 months of the first study treatment

• History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins

• History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; Epirubicin > 900 mg/m^2; Mitoxantrone > 120 mg/m^2 and idarubicin > 90 mg/m^2

• Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0

• History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma

• Current unstable angina

• History of symptomatic congestive heart failure (CHF), or ventricular arrhythmia requiring treatment

• History of myocardial infarction within 6 months of enrollment

• Left ventricular ejection fraction (LVEF) < 50% within 28 days of enrollment

• History of decreased LVEF to < 50% or symptomatic CHF with previous adjuvant trastuzumab treatment

• Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy

• Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)

• Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment

• Current pregnancy or lactation

• Current known infection with human immunodeficiency virus (HIV), active hepatitis B, and/or hepatitis C virus

• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol