Breast Cancer
Conditions
Keywords
high risk breast cancer, low risk breast cancer, uPA, urokinase-type plasminogen activator, PAI, plasminogen activator inhibitor-type
Brief summary
In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological criteria. Due to their high prognostic impact, the tumour-biological invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are potential candidates to effectively assess the risk of relapse in node-negative breast cancer. This study is aimed to compare the risk assessment by the traditional clinico-pathological factors and by tumour-biological factors. The second study question refers to the comparison between an adjuvant combination treatment with FE100C\*6 and a sequential treatment with FE100C\*3 and Docetaxel\*3.
Detailed description
1. To compare FEC\*6 with FEC\*3 followed by DOC\*3 with regard to: * the primary endpoint of the study: Disease-Free Survival (DFS) * the secondary endpoints: Overall Survival (OS), compliance, and toxicity of chemotherapy in each patient group 2. To compare patients with low risk according to clinico-pathological versus those according to biological risk criteria with regard to: * the proportion of low risk versus high risk patients * DFS * OS (secondary endpoint)
Interventions
DRUG5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel
Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks
Sponsors
GBG Forschungs GmbH
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological proven primary breast cancer * Tumour size \>0.5 cm and \<5 cm (pT1b-pT2, pN0, M0) * Axillary lymph nodes tumour free (node-negative disease) * Adequate surgical procedure: R0-resection and axillary dissection with more than 10 lymph nodes examined or adequate sentinel procedure in a qualified centre * Frozen tumour tissue available (for analysis of biological markers and microarrays, centres with biological risk assessment only). The material has to be stored in liquid nitrogen immediately after excision. * Paraffin blocks or (at least) pathology slides of primary tumour (stained and unstained) and axillary nodes (stained) available for central review. * HER-2/neu determination by immunohistochemistry. Patients will be stratified to be HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+ and FISH positive). * No distant metastasis * Age \>18 years, \<70 years * Performance status ECOG \<2 (WHO Performance Status 0-1) * Adequate cardiac function (echocardiographically measured left ventricular ejection fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%) * Adequate bone function (neutrophil count \>1.5 x109 /l and platelet count \>100 x109 /l) * Adequate renal function (serum creatinine \<120 µmol/l or 1.35 mg/dl) and hepatic function (serum bilirubin \<1 x UNL, ASAT or ALAT (SGOT or SGPT) \<2,5 x UNL) * Before patient registration/randomization, written informed consent must be obtained according to ICH/EU GCP, and national/local regulations
Exclusion criteria
* Chemotherapy contraindicated * Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the sentinel node. * Other concomitant pathology compromising survival (at entry), or preventing the administration of chemotherapy with either FEC or Docetaxel * Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study * Estimated life-expectancy \<10 years (irrespective of breast cancer diagnosis) * Patient not accessible for treatment and follow up * Endocrine treatment not according to the latest standard recommendations of the AGO Kommission Mamma * Pregnancy, lactation (sufficient non-hormonal contraception in fertile women required) * Surgery more than six weeks ago at the start of chemotherapy * Pre-existing polyneuropathy * Previous or concomitant other malignancy (including contralateral breast cancer) except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix * Prior chemotherapy or radiotherapy or endocrine therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival | after 10 years follow up |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | after 10 years follow up |
Countries
Germany
Outcome results
None listed