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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: DOCETAXEL

Study type

Interventional

Funder types

Industry

Identifiers

XRP6976D_2502

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

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