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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel

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