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

September 1, 2009 updated by: Sanofi

A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.

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

Study Overview

Status

Completed

Conditions

Breast Neoplasms

Intervention / Treatment

Drug: DOCETAXEL

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France
    - Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of clinical and radiological response evaluated according to RECIST criteria Time Frame: During the study conduct	During the study conduct

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of histological response Time Frame: During the study conduct	During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria