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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00617968
First received: February 6, 2008
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
 Drug: DOCETAXEL
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Rate of clinical and radiological response evaluated according to RECIST criteria [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of histological response [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2003
Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617968

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie BILLON Sanofi
  More Information

No publications provided

Responsible Party: Nathalie Billon/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00617968     History of Changes
Other Study ID Numbers: XRP6976D_2502
Study First Received: February 6, 2008
Last Updated: September 1, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013