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

NCT ID: NCT00679211

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-04-30

Brief Summary

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

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab emtansine

Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.

Group Type: EXPERIMENTAL

Trastuzumab emtansine [Kadcyla]

Intervention Type: DRUG

Intravenous repeating dose

Interventions

Trastuzumab emtansine [Kadcyla]

Intravenous repeating dose

Intervention Type: DRUG

Other Intervention Names

Trastuzumab-MCC-DM1; T-DM1

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellie Guardino, M.D., PhD.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

TDM4374g

Identifier Type: -

Identifier Source: org_study_id