Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naïve Patients With HER2-Positive Breast Cancer

Phase 1

• Conditions: Patients with human epidermal growth factor receptor-2 (HER2) positive stage II or III breast cancer; MedDRA version: 9.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancer

• Registration Number: EUCTR2008-000709-12-FR
• Lead Sponsor: Cephalon France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-01
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified