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

Phase 2

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00617968
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-06
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-18
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of clinical and radiological response evaluated according to RECIST criteria	During the study conduct

Secondary Outcome Measures

Name	Time	Method
Rate of histological response	During the study conduct

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France