Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel + Anthracycline x 4 Cycles Followed by Docetaxel Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed ≥ 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®- Based Chemotherapy

Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer

Secondary:

• Clinical response rate
• To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer
• Type of surgery (radical/conservative)

Inclusion Criteria:

• Histologically verified breast cancer
• Large (≥ 3 cm) breast cancer
• IIb-IIIa stage
• ECOG (Eastern Cooperative Oncology Group) status: 0-1-2
• Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10^9, Platelets ≥100 000)
• Laboratory results:
• Bilirubin ≤ Upper Limit Normal (ULN)
• Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 ULN, Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 ULN,
• Alk.phosph. ≤ 5.0 ULN,
• Creatinin ≤ ULN, if borderline calculated at ≤ 60ml/min
• Normal cardiac function (the result of Left Ventricular Ejection Function (LVEF) must be above the lower limit of normal for the institution)
• Negative pregnancy test
• Hormonal receptor status assessed

Exclusion Criteria:

• Pregnancy or lactation
• SGOT and/or SGPT > 1.5 upper limit normal, associated with Alk.phosph > 2.5 ULN
• Serious medical condition including but not limited to:
• Uncontrolled hypertension
• Active ulcus pepticum
• Non-stable diabetes mellitus
• Other contraindication of steroid treatment
• Myocardial infarction within the last 6 months prior study entry
• Significant neurologic/psychiatric disorders
• Active infection
• Peripheral neuropathy grade ≥ 2
• Unstable angina
• Severe arrhythmia
• Participation in other clinical trial
• Prior surgery, chemotherapy, hormonotherapy for breast cancer
• Past or current history of neoplasm other than breast cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 7 years
• History of hypersensitivity to the investigational products or to drugs with similar chemical structures
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• Treatment with any investigational product in the last 1 month before study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.