Breast Neoplasms
Conditions
Keywords
Breast Cancer, Neoadjuvant therapy
Brief summary
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria). The secondary objectives are: * to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria, * to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.
Interventions
intravenous administration
DRUGdocetaxel
intravenous administration
DRUGtrastuzumab
intravenous administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven invasive breast adenocarcinoma * Localized breast cancer: stage II and III * Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate) * After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)
Exclusion criteria
* Bilateral and inflammatory breast cancer * Abnormal Left Ventricular Ejection Fraction * Distant metastases or locoregional relapse * Inadequate organ functions The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. | treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response Rate, Rate of breast conservation, Progression-Free Survival, Overall Survival, pathological response according to NSABP and Sataloff criteria for patients who underwent surgery | treatment period |
| Safety and tolerability profile | treatment period |
Countries
Belgium, Brazil, France, Germany, Poland, Tunisia, United Kingdom, Uruguay
Outcome results
None listed