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

NCT00617968 | Completed Phase 2

• 1 other identifier: XRP6976D_2502
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Rate of clinical and radiological response evaluated according to RECIST criteria

  During the study conduct

Secondary Outcomes (1)

• Rate of histological response

  During the study conduct

Interventions

DOCETAXEL DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Nathalie BILLON

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: October 1, 2003
• Study Completion: June 1, 2005
• Last Updated: September 2, 2009

Record last verified: 2009-09

Locations

FR (1)