Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
