Primary mamma carcinoma MedDRA version: 14.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Epirubicin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: EPIRUBICIN HYDROCHLORIDE
CAS Number: 56390091
Product Name: Docetaxel
Pharmaceutical Form: Solution for infusi
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion 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 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 • Written informed consent of the patient including compliance of the patient regarding the therapy and the follow-up must be available before enrolment and documented according to the local regulations. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
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 • Florid ulcus, unstable diabetes mellitus • Previously diagnosed tumor with exception of basalioma or in situ carcinoma of the cervix or other cancers having been treated curatively and having been followed by a disease-free interval of 6 months before study entry and at low doses (< 20 mg Methylprednisolone or equivalents) • Clear contraindication for the application of corticosteroids • Contraindication of the planned therapy: - hypersensitivity to one of the trial drugs (Docetaxel, Cyclophosphamide and Epirubicine) - extensive inflammatory condition of oral or gastrointestinal mucous membrane • Lack of compliance • Concomitant participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimation of the complete response rate of invasive tumor cells in the breast confirmed by histological examinations;Secondary Objective: Tumor response according to clinical criteria Tumor response according to pathological criteria Rate of breast-conserving surgery Toxicity associated with the therapy Disease free survival Overall survival ;Primary end point(s): Estimation of the complete response rate of invasive tumor cells in the breast confirmed by histological examinations;Timepoint(s) of evaluation of this end point: At end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor response according to clinical criteria determined by sonogrphy at surgery. Tumor response according to pathological criteria determined by histology at surgery. Rate of breast-conserving surgery Toxicity associated with the therapy at each performed chemotherapy cycle. Disease free survival until study end Overall survival until study end ;Timepoint(s) of evaluation of this end point: At end of therapy and end of study | — |
Countries
Germany
Contacts
Public ContactZentrum für Klinische Studien
ZKS Leipzig - KKS
Outcome results
None listed