Clinical trial NCT00461344: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ductal Carcinoma
Keywords: Breast
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary outcomes:
measure: 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)
Other outcomes:
Locations:
Study officials:
affiliation: sanofi-aventis Hungary
name: László Erős
role: STUDY_DIRECTOR
References: