Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

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.