Breast Cancer Clinical Trial
— MYOHERTAXOfficial title:
Phase II Multicentre Open Label Study Evaluating the Efficacy and Safety of Liposomal Doxorubicin, Trastuzumab, Docetaxel as First-line Treatment of Patients With HER2 Positive Metastatic Breast Cancer
This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu positive breast cancer.
Status | Terminated |
Enrollment | 60 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women with histologically documented metastatic or locally advanced metastatic HER2/neu positive breast cancer at 1st line of palliative chemotherapy. - In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion. - In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose = 240 mg/m2 of doxorubicin or 450 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion. - Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment). - Previous radiotherapy is authorized, if discontinued = 4 weeks prior to inclusion in the study and if < 10% of the bone marrow was within the irradiated area. - Age = 18 years. - Performance status 0,1, or 2. - Life expectancy = 3 months. - Evaluable disease. - Normal LVEF (multigated acquisition [MUGA] scan or echocardiography). - Normal haematological, hepatic and renal parameters: neutrophils = 1.5 x 10^9/l; platelets = 100 x 10^9/l; hemoglobin (Hb) = 6 mmol/L; total bilirubin = 1.5 times the upper limit of normal (ULN); transaminases = 2.5 x ULN; alkaline phosphatase = 2.5 x ULN; creatinine = 1.5 x ULN. - Dated and signed written informed consent. Exclusion Criteria: - Previous chemotherapy for metastatic disease. - History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer. - History of congestive heart failure or myocardial infarction = 1 year; cardiac function: NYHA = 2 or LVEF < 50%. - Uncontrolled significant heart disease, such as unstable angina. - Poorly controlled hypertension. - Performance status 3, 4. - Symptomatic or progressive brain metastases. - Active infection or other serious underlying disease. - Concomitant participation in other clinical trials. - Pregnant women or nursing mothers; patients of childbearing potential without effective contraception. - Absolute medical contraindication to the use of corticosteroid premedication. - Allergy to polysorbate 80, doxorubicin, or egg lecithin. - NCI-CTC grade > 1 peripheral neuropathy. - Patients not able to comply with regular medical follow-up |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Ziekenhuis Rijnstate | Arnhem | |
Netherlands | Wilhelmina Ziekenhuis | Assen | |
Netherlands | Catharina-Ziekenhuis | Eindhoven | |
Netherlands | Ikazia Ziekenhuis | Rotterdam | |
Netherlands | Maxima Medisch Centrum | Veldhoven | |
Netherlands | VieCuri MC | Venlo | |
Netherlands | Streekziekenhuis Koningin Beatrix | Winterswijk |
Lead Sponsor | Collaborator |
---|---|
Laurence J.C. van Warmerdam | Cephalon, Sanofi |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiotoxicity (definite or probable cardiac death) | treatment period | Yes | |
Primary | Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV | treatment period | Yes | |
Primary | Decline in left ventricular ejection fraction (LVEF) of = 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III) | treatment period | Yes | |
Primary | Decline in LVEF of = 10% to < 50% without signs or symptoms of CHF | treatment period | Yes | |
Secondary | Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification | treatment period | Yes | |
Secondary | Response rate | treatment period | No | |
Secondary | Median time to progression | treatment period | No | |
Secondary | Progression free survival | treatment period | No |
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