eoadjuvant, sequential chemotherapy with docetaxel followed by Fluorouracil, Epirubicin, and Cyclophosphamid every 3 weeks - genome wide expression analysis for identification of a predictive gene signature in patients with primary breast cancer - EXPRESSIO

Phase 1

• Conditions: 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: 14.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10021974Term: Inflammatory breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-006381-29-DE
• Lead Sponsor: niversitätsmedizin Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-12
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

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) < 2,5 x ULN, bilirubin and creatinine in normal range (if creatinine is out of normal range creatinine clearance has to be > 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

- 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 < 50% or unstable Angina Pectoris, history of myocard infarction within one year of randomisation, uncontrolled hypertension > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified