Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Phase 2

Terminated

• Conditions: Ductal Carcinoma

• Registration Number: NCT00461344
• Lead Sponsor: Sanofi

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 safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer

* Type of surgery (radical/conservative)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-06
• Study First Submitted: 2007-04-17
• Study First Submitted QC: 2007-04-17
• Study First Posted: 2007-04-18
• Study Completion: 2007-08
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-01
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer

Secondary Outcome Measures

Name	Time	Method
Secondary: 1. Clinical response rate 2. to investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer 3. Type of surgery (radical/conservative)