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.

Sanofi1 site in 1 country5 target enrollmentOctober 2003

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Neoplasms
Sponsor: Sanofi
Enrollment: 5
Locations: 1
Primary Endpoint: Rate of clinical and radiological response evaluated according to RECIST criteria
Status: Completed
Last Updated: 16 years ago

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

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

June 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

•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

•Inflammatory or T4 breast cancer
•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