Status:
COMPLETED
GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
Brief Summary
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00617968
Start Date
October 1 2003
End Date
June 1 2005
Last Update
September 2 2009
Active Locations (1)
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1
Sanofi-Aventis
Paris, France