GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer

Study Overview
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Brief Summary
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Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.

Official Title
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A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: DOCETAXEL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DOCETAXEL|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical and radiological response evaluated according to RECIST criteria |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of histological response |  | During the study conduct |