Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
- Conditions
- Breast CancerNeoplasm Metastasis
- Interventions
- Drug: Non pegylated liposomal doxorubicin and docetaxel
- Registration Number
- NCT00377559
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- Brief Summary
This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.
- Detailed Description
Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease.
Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer.
- 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 ≤ 360 mg/m2 of doxorubicin or 600 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1. Non pegylated liposomal doxorubicin and docetaxel Myocet+docetaxel
- Primary Outcome Measures
Name Time Method Cardiotoxicity (definite or probable cardiac death) treatment period Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV treatment period Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF treatment period Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III) treatment period
- Secondary Outcome Measures
Name Time Method Progression free survival treatment period Response rate treatment period Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification treatment period Median time to progression treatment period
Trial Locations
- Locations (10)
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Wilhelmina Ziekenhuis
🇳🇱Assen, Netherlands
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
Sint Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
VieCuri MC
🇳🇱Venlo, Netherlands
Ziekenhuis Walcheren
🇳🇱Vlissingen, Netherlands
Catharina-Ziekenhuis
🇳🇱Eindhoven, Netherlands
Mesos Medisch Centrum
🇳🇱Utrecht, Netherlands
Streekziekenhuis Koningin Beatrix
🇳🇱Winterswijk, Netherlands