A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.
Human epidermal growth factor receptor 2 (HER2)-positive.
No prior chemotherapy for their metastatic breast cancer (MBC).
Measurable disease.
Age ≥ 18 years.
For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.
You may not be if
History of any chemotherapy for MBC.
An interval of \< 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.
Trastuzumab ≤ 21 days prior to randomization.
Hormone therapy \< 7 days prior to randomization.
Current peripheral neuropathy of Grade ≥ 3.
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.
Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.
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 2 months prior to randomization.
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin \> 500 mg/m\^2; epirubicin \> 900 mg/m\^2; mitoxantrone \> 120mg/m\^2 and idarubicin \> 90 mg/m\^2.
Current unstable angina.
History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.
History of myocardial infarction within 6 months prior to randomization.
Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.
History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.
Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization.
Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.
Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.
Current pregnancy or lactation.
History of receiving any investigational treatment within approximately 28 days prior to randomization.
Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus.
History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.
Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Clareo Health | A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
