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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00617968
• Date of registration: 06/02/2008
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer
• Scientific 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.
• Date of first enrolment: October 2003
• Target sample size: 5
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00617968
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Nathalie BILLON
• Affiliation: Sanofi

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: DOCETAXEL

Primary Outcome(s)

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

Secondary Outcome(s)

Rate of histological response [Time Frame: During the study conduct]

Secondary ID(s)

XRP6976D_2502

Source(s) of Monetary Support

Please refer to primary and secondary sponsors