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

NCT ID: NCT00617968

Last Updated: 2009-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2005-06-30

Brief Summary

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

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

DOCETAXEL

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Nathalie BILLON

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Paris, , France

Countries

France

Other Identifiers

XRP6976D_2502

Identifier Type: -

Identifier Source: org_study_id