Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer
- 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
- 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
- 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