Clinical trial NCT00617968: GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 5
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Rate of clinical and radiological response evaluated according to RECIST criteria
timeFrame: During the study conduct
Secondary outcomes:
measure: Rate of histological response
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Nathalie BILLON
role: STUDY_DIRECTOR
References: