Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cephalon, Inc.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2.
Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria.
The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
The participant has an LVEF of at least 55% as assessed by multigated acquisition (MUGA) scan (preferred) or echocardiography.
The participant has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.
You may not be if
The participant:
Has received previous cancer therapy for breast cancer.
Has any history of CHF, angina pectoris, or myocardial infarction.
Has uncontrolled hypertension.
Has infection, peptic ulcer, or unstable diabetes mellitus.
Has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
Has impaired hepatic or renal function.
Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
Has used an investigational drug within one month before the screening visit.
Has a known hypersensitivity to any of the study drugs or to their active ingredients.
Has an inflammatory breast cancer.
Has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Clareo Health | Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
