Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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) |
|---|---|
| Condition | Ductal Carcinoma |
| Intervention | Drug: Docetaxel Drug: Doxorubicin |
| Phase | Phase 2 |
| Sponsor | Sanofi |
| Responsible Party | Sanofi |
| ClinicalTrials.gov Identifier | NCT00461344 |
| First Received | April 17, 2007 |
| Last Updated | April 1, 2008 |
| Last verified | April 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 17, 2007 |
|---|---|
| Last Updated Date | April 1, 2008 |
| Start Date | July 2004 |
| Estimated Primary Completion Date | August 2007 |
| Current Primary Outcome Measures | Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer |
| Current Secondary Outcome Measures | 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) [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer |
|---|---|
| Official Title | 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 |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Ductal Carcinoma |
| Intervention | Drug: Docetaxel Drug: Doxorubicin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 20 |
| Estimated Completion Date | August 2007 |
| Estimated Primary Completion Date | June 2005 |
| Eligibility 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Hungary |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00461344 |
|---|---|
| Other Study ID Numbers | XRP6976D_2504 |
| Has Data Monitoring Committee | No |
| Information Provided By | Sanofi |
| Study Sponsor | Sanofi |
| Collaborators | Not Provided |
| Investigators | Study Director: László Erős sanofi-aventis Hungary |
| Verification Date | April 2008 |