Patients with human epidermal growth factor receptor-2 (HER2) positive stage II or III breast cancer MedDRA version: 9.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer
Conditions
Interventions
Trade Name: MYOCET
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: CEP-19562
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Cephalon France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are included in the study if all of the following criteria are met: (a) Treatment-naïve patients have stage II or III invasive breast cancer histologically/cytologically proven and overexpressing human epidermal growth factor reeptor 2 (HER2) as demonstrated by fluorescence in situ hybridization (FISH). (b) Patients have at least 1 bidimensionally measurable lesion according to the WHO criteria. (c) The patient is a woman 18 to 70 years of age, inclusive. (d) Written informed consent is obtained. (e) The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. (f) The patient has an LVEF of at least 55% as assessed by multiple-gated acquisition (MUGA) scan (preferred) or echocardiography. (g) The patient has haematology and serum chemistry laboratory test results within the following ranges: • at least 2x10^9 neutrophils/L • at least 100x10^9 platelets/L • total bilirubin serum concentrations not exceeding the normal laboratory reference range • aspartate aminotransferase (AST) serum levels not exceeding 2.5 times the upper limit of normal (ULN) • alanine aminotransferase (ALT) serum levels not exceeding 2.5xULN • alkaline phosphatase (ALP) serum levels not exceeding 5.0xULN • serum creatinine serum levels not exceeding 1.5xULN (h) Women of childbearing potential (not surgically sterile or 2 years postmenopausal) 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 4 months after the last administration of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. (i) The patient must be willing and able to comply with study assessments and willing to return to the clinic for further treatment and follow-up as specified in this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: (a) The patient has received previous cancer therapy for breast cancer. (b) The patient has any history of coronary heart failure (CHF), angina pectoris, or myocardial infarction. (c) The patient has uncontrolled hypertension. (d) The patient has infection, peptic ulcer, or unstable diabetes mellitus. (e) The patient has been treated with live virus vaccines within 8 weeks before the first administration of study drug. (f) The patient has impaired hepatic or renal function. (g) The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) (h) The patient has used an investigational drug within 1 month before the screening visit. (i) The patient has a known hypersensitivity to any of the study drugs or to their active ingredients. (j) The patient has an inflammatory breast cancer. (k) The patient has any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of up to 8 cycles (24 weeks) of MYOCET plus cyclophosphamide and trastuzumab for 4 cycles followed by docetaxel plus trastuzumab for 4 cycles (MCH?TH) with free doxorubicin plus cyclophosphamide alone for 4 cycles followed by docetaxel plus trastuzumab for 4 cycles (AC?TH), each on day 1 of a 21-day cycle, as assessed by the proportion of patients with pathological complete response (pCR).;Secondary Objective: To compare the efficacy of each treatment group as assessed by the following: • the proportion of patients who achieve an objective response (complete response[CR] or partial response [PR]) as defined by World Health Organization (WHO) • the proportion of patients with progression-free survival (PFS) 2 years after being randomly assigned to treatment. To compare the safety of each treatment assessed by the following: • the occurrence of New York Health Association (NYHA) functional class III or IV congestive heart failure (CHF) at any time during the study • a reduction from baseline left ventricular ejection fraction (LVEF) at any time during the study •occurrence of adverse events throughout the study, characterized by the National Cancer Institute Common Toxicity Criteria of Adverse Events (NCI CTCAE) version 3. ;Primary end point(s): The primary efficacy measure is an outcome of pathological complete response (pCR) or ductal carcinoma in situ based upon histologic examination, as confirmed by a central panel of experts, of breast tissue resected. | — |
Countries
Austria, Belgium, France, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed