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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00712881
First received: July 8, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

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) 5 years after being randomly assigned to treatment. [ Time Frame: 5 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 ]

Enrollment: 126
Study Start Date: October 2008
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (1) Investigational Product 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).
Active Comparator: (2) Comparison Therapy 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712881

Locations
Austria
Teva Investigational Site 16
Kufstein, Austria
Teva Investigational Site 15
Wien, Austria
Belgium
Teva Investigational Site 9
Bruxelles, Belgium
Teva Investigational Site 29
Yvoir, Belgium
France
Teva Investigational Site 5
Nancy, France
Teva Investigational Site 33
Reims, France
Teva Investigational Site 8
Vandoeuvre-Les-Nancy, France
Germany
Teva Investigational Site 30
Aachen, Germany
Teva Investigational Site 25
Dusseldorf, Germany
Teva Investigational Site 11
Dusseldorf, Germany
Teva Investigational Site 32
Essen, Germany
Teva Investigational Site 14
München, Germany
Teva Investigational Site 27
München, Germany
Teva Investigational Site 12
Rheinfelden, Germany
Italy
Teva Investigational Site 20
Napoli, Italy
Teva Investigational Site 23
Roma, Italy
Teva Investigational Site 21
Verona, Italy
Spain
Teva Investigational Site 3
Barcelona, Spain
Teva Investigational Site 26
Barcelona, Spain
Teva Investigational Site 1
Lleida, Spain
Teva Investigational Site 2
Zaragoza, Spain
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00712881     History of Changes
Other Study ID Numbers: C19562/2037/BC/EU, 2008-000709-12
Study First Received: July 8, 2008
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Trastuzumab
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 22, 2013