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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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

No

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

February 6, 2008

First Posted (Estimate)

February 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP6976D_2502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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