Breast Neoplasms
Conditions
Brief summary
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.
Interventions
DRUGDOCETAXEL
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status. * Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral * Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram) * Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers) * HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry * Histological grade I or II * Menopausal patients aged greater than or equal to 60 years * Patients with ECOG PS greater than or equal to 2 * Satisfactory hematological, hepatic and renal functions: * Hemoglobin greater than or equal to 10 g/dL * Platelet count greater than or equal to 100x109/L * Polynuclear neutrophil count greater than 1.5x109/L * Creatinine less than or equal to ≤ 1.5 ULN * AST/ALT less than or equal to 1.5 ULN * Alkaline phosphatases less than or equal to 2.5 ULN * Patients able to be followed throughout the study * Patient's consent obtained.
Exclusion criteria
* Inflammatory or T4 breast cancer * T1 tumor * Patients whose tumor is deemed by the doctor to be difficult to evaluate * Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset * RE and RP receptors negative or unknown * HER 2/neu positive at 3 + * Non-menopausal patients * Surgical biopsy and/or ganglion dissection before neoadjuvant treatment * Significant poorly controlled cardiac disorders, such as unstable angina pectoris, poorly controlled heart failure, arrhythmia requiring treatment, or myocardial infarction within the last 3 months * Cardiovascular, hepatic, neurological or endocrine disease, or other major systemic disease that makes it difficult to conduct the protocol or to interpret the results * Previous history of cancer that occurred within the last 10 years, with the exception of cervical cancers and basocellular skin cancers that were properly treated * Allergy to polysorbate 80 * Hypersensitivity to docetaxel * Participation in another clinical trial with one of the study medicinal products during the 30 days prior to entry in the study * Patients who are unable to undergo medical monitoring for geographical, social or psychological reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical and radiological response evaluated according to RECIST criteria | During the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| Rate of histological response | During the study conduct |
Countries
France
Outcome results
None listed