EUCTR2008-003064-19-DE
Active, not recruiting
Phase 1
Phase-IIb-Study to Evaluate the Effect of a Neoadjuvant Chemotherapy with Docetaxel, Epirubicine and Cyclphosphamide (TEC) in Patients with primary HER-2 neu Negative Mammacarcinoma - NeoTEC-Studie
niversität Leipzig0 sitesOctober 23, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary mamma carcinoma
- Sponsor
- niversität Leipzig
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women with histologically verified mamma carcinoma (assessment of estrogen and progesterone receptors, grading, negative HER\-2/neu status)
- •All receptor\-negative mamma carcinoma starting from cT1c, all receptor\-positive mamma carcinoma starting from cT3, cT4 includes inflammatory mamma carcinoma
- •In case of cT2 and receptor\-positivity, N\+ is required and can also be detected with sentinel node biopsy
- •In case of cT1c and receptor\-positivity, a positive lymph node must be verified with sentinel node biopsy (pNsn\+)
- •Clinically and with an imaging technology (sonography or mammography) measurable primary tumor
- •Sufficient bone marrow reserve: number of neutrophils \>\= 1,5 x 1000000000/L, number of thrombocytes \>\= 100 x 1000000000/L, hemoglobin \>\= 6,2 mmol/L
- •Sufficient liver and renal function: bilirubin \<\=1 x upper limit of quantification (ULQ), ASAT (SGOT) and ALAT (SGPT) \< 1,5 x ULQ, alcalic phosphatase \< 1,5 x ULQ, Creatinine \< 1 x ULQ (if creatinine \> ULQ creatinine clearance must be \> 60 mL/minute)
- •Age\-appropriate cardiologically normal findings as documented by ECG and LVEF (echocardiographical) assessments before beginning the therapy
- •ECOG\-performance\-status of 0\-2
- •Age \>\=18 years
Exclusion Criteria
- •Pregnant or nursing women. Positive pregnancy test (urine or serum) within 7 days before registration
- •Previous surgical, cytostatic or hormonal therapy (with exception of hormone substitution or contraception), no previous immune or radiation therapy
- •Women with child bearing potency (menopause according to hormone status) without effective non\-hormonal contraception (intra\-uterine devices – spirals, condoms in combination with additional contraceptic measures, vasectomised partner) during the participation in the study and 6 months after the end of study therapy.
- •Bilateral localisation of tumors
- •Evidence of distant metastases after complete staging with chest X\-ray, upper abdomen sonography, and/or CT and bone scintigraphy
- •Pre\-existing motor or sensor neurotoxicity \> grade 2 (according to NCl criteria)
- •Pre\-existing cardiac disease not permitting the participation in this study (e.g. severe heart insufficiency or unstable angina pectoris, cardiac infarction within one year before study entry, uncontrolled hypertension, therapy resistant arrhythmia
- •Significant neurological or psychiatric disease in the anamnesis (including psychotic disorders, dementia or seizures) compromising the understanding of the trial and consent to the trial.
- •Drug abuse
- •Active infection
Outcomes
Primary Outcomes
Not specified
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