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

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00712881

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: MYOCET® Plus Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles Drug: Free Doxorubicin Plus Cyclophosphamide, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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-Naive Patients With HER2-Positive Breast Cancer

Further study details as provided by Cephalon:

Primary Outcome Measures:

Pathological complete response (pCR) in breast, upon histologic examination. [ Time Frame: 24 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the proportion of patients who achieve an objective response [Complete Response (CR) or Partial Response (PR)] as defined by WHO guidelines. [ Time Frame: 24 weeks of therapy ] [ Designated as safety issue: No ]
Occurrence of class III or IV (NYHA) congestive heart failure (CHF) at any time during the study. [ Time Frame: 24 weeks + ] [ Designated as safety issue: Yes ]
Reduction from baseline left ventricular ejection fraction (LVEF) at any time during the study. [ Time Frame: 24 weeks + ] [ Designated as safety issue: Yes ]
Occurrence of adverse events throughout the study, characterized by NCI CTCAE version 3 guidelines. [ Time Frame: 24 weeks + ] [ Designated as safety issue: Yes ]
Assess the proportion of patients with progression-free survival (PFS) 2 years after being randomly assigned to treatment. [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]
Assess the proportion of patients who achieve pathological complete response (pCR) in breast and axillary lymph node. [ Time Frame: 24 weeks of therapy ] [ Designated as safety issue: No ]
Assess the proportion of patients with conservative surgery. [ Time Frame: 24 weeks + ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
(1) Investigational Product: Experimental	Drug: MYOCET® Plus Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles MYOCET® (60 mg/m2) and cyclophosphamide (600 mg/m2) and trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks) once every 3 weeks for 4 cycles followed by docetaxel (100 mg/m2) and trastuzumab (6 mg/kg) once every 3 weeks for 4 cycles (MCH→TH).
(2) Comparison Therapy: Active Comparator	Drug: Free Doxorubicin Plus Cyclophosphamide, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles Free doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) once every 3 weeks for 4 cycles followed by docetaxel (100 mg/m2) and trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) once every 3 weeks for 4 cycles (AC→TH).

Detailed Description:

A multicentre, open-label, randomized, Phase 2 study to evaluate the efficacy and safety of treatment with MYOCET® in combination with cyclophosphamide and trastuzumab versus free doxorubicin in combination with cyclophosphamide, each followed by docetaxel and trastuzumab, in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Cephalon France ( Sponsor's Medical Expert )
Study ID Numbers:	C19562/2037/BC/EU, EudraCT number: 2008-000709-12
Study First Received:	July 8, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00712881
Health Authority:	France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Trastuzumab
Breast Neoplasms

Cyclophosphamide
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009