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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014