Status:
COMPLETED
Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
Lead Sponsor:
Cephalon, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycl...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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 (Any women becoming pregnant during the study will be withdrawn from the study.)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).
- Note: Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
October 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2015
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00712881
Start Date
October 13 2008
End Date
September 17 2015
Last Update
February 23 2024
Active Locations (22)
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1
Teva Investigational Site 16
Kufstein, Austria
2
Teva Investigational Site 15
Vienna, Austria
3
Teva Investigational Site 9
Brussels, Belgium
4
Teva Investigational Site 29
Yvoir, Belgium