Eligible will be only females between 18 - 70 years of age, suffering from histologically confirmed primary breast cancer, nodal status positive or negative, phase cT2, cT3, or cT4 including inflammatory disease. Metastatic disease is excluded. All patients will be treated with 3 cycles Docetaxel and 3 cycles FEC. MedDRA version: 14.1 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and po
Conditions
Interventions
Trade Name: Taxotere
Product Name: Docetaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 114977-28-5
Other descriptive name: DOCETAXEL
Concent
Sponsors
Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - histologically confirmed breast carcinoma (including determination of estrogen and progesteron receptor status, grading, her-2/neu-state) - phase cT2, cT3, or cT4 including inflammatory breast carcinoma - nodal negative or positive patients - no evidence for distant metastasis after complete staging including chest X-ray, abdominal sonography, and bone scan within 4 weeks prior to randomisation - no prior surgical, cytostatical, or hormonal therapy (excluding hormonal substitution or contraception), no prior radiation or immunotherapy - primary tumor which is clinical and/or measurable in 2 dimensions by an imaging analysis (obligatory is bilateral mamogram and breast sonography, fakultativ is MRI) - adequate reserve of bone marrow: neutrophils = 1.5 x 10*9/L, platelets = 100 x 10*9/L, hemoglobin = 100 g/L - adequate hepatic and renal function; ASAT (SGOT) and ALAT (SGPT) 60 ml/minute) - normal cardiologic state according to age, estimated by ECG and echocardiography within 4 weeks before start of treatment - ECOG performance state 0-2 - age 18 to 70 years - negative pregnancy test (urine or serum) within 7 days prior to registration for woman of childbearing potential - patients have to be available for treatment and follow up examinations. Treatment of a patient who has been randomised to study has to take place at a participating site (site of PI or sub-investigator). The participating site is also incumbent on documentation of follow up examinations. - signed, written informed consent (approved by the Ethics Committee) obtained prior to registration - including patient´s adopted acceptance of therapy and follow up visits - signed, written informed consent of patient for gene expression analysis and the related examinations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnant or lactating woman; patients with childbearing potential have to use an effective mechanic form of contraception - current motoric or sensoric neuropathy = grade 2 (according to NCI criteria) - pre-existing cardiac diseases which do not admit participating on the study (f. e. LVEF 165/90 mm Hg, high risk, uncontrolled arrhytmia) - history of significant neurological or psychiatric disease (including psychotic disease, dementia and attacks), which could affect understanding of study or agreement on study. - current uncontrolled infection - current gastric ulcer, unstable diabetes mellitus - history of other malignancy except for carcinoma in situ of the cervix or basal cell carcinoma or an other tumor with a disease-free interval of > 12 months after treatment - current daily chronic treatment with corticosteroids (dose of > 20 mg methylprednisolone equivalent), which started within 6 months prior to randomisation - contraindication to treatment with corticosteroids - current treatment with other experimental medication or participation on an other clinical trial with investigative substances within 30 days prior to registration - any other current anticancer therapy - current therapy with sex hormones (treatment has to be discontinued before registration) - male patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: identification and validation of a predictive gene expression profile for pCR to treatment with 3 x docetaxel followed by 3 x FEC (q3w) in patients with breast cancer;Secondary Objective: - identification and validation of a predictive gene expression profile for cCR to treatment with docetaxel - FEC - validation of in-vitro generated gene expression signatures for docetaxel as well as FEC - estimation of the tumor response rate (clinical and pathological confirmed complete response, pCR) - ratio of breast-preserving surgeries after chemotherapy;Primary end point(s): Primary endpoint is the identification and validation of a predictive gene expression signature for pCR to therapy with docetaxel-FEC. Secondary endpoints are - identification and validation of a predictive gene expression profile for cCR to treatment with docetaxel - FEC - validation of in-vitro generatied gene expression signatures for docetaxel as well as FEC - estimation of the tumor response rate (clinical and pathological confirmed complete response, pCR) - ratio of breast-preserving surgeries after chemotherapy | — |
Countries
Germany
Outcome results
None listed