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

Breast Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617968
• Other study ID #: XRP6976D_2502
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2008
• Last updated: September 1, 2009
• Start date: October 2003
• Est. completion date: June 2005

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• DOCETAXEL

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical and radiological response evaluated according to RECIST criteria		During the study conduct	No
Secondary	Rate of histological response		During the study conduct	No