Status:
TERMINATED
Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Ductal Carcinoma
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 safe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00461344
Start Date
July 1 2004
End Date
August 1 2007
Last Update
April 3 2008
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