Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Patients With HER2-Positive Breast Cancer

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluate the efficacy and safety of treatment with MYOCET® in combination with Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab

Criteria

Main Inclusion Criteria:

• Treatment-naive patients with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of human epidermal growth factor receptor 2 (HER2).

• Patients have at least one bidimensionally measurable lesion according to the WHO criteria.

• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• The patient has an LVEF of at least 55% as assessed by multiple-gated acquisition (MUGA) scan (preferred) or echocardiography.

• The patient 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 Criteria:

The patient:

• 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 (Any women becoming pregnant during the study will be withdrawn from the study.)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).