Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Ductal Carcinoma

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Doxorubicin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|nan|
|Drug: Doxorubicin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast