Patients with primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, pM0 MedDRA version: 19.1 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Taxotere 80 mg
Product Name: Taxotere 80 mg
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 114977-28-5
Other descriptive name: DOCETA
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1.] Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, pM0 [2.] No evidence of HER2/neu overexpressing (IHC neg or +) or amplifying (FISH - ) tumor [3.] Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as at least one criterion of the following: ‘pT"2, histopathological grade 3, age =18 years of age [6.] Performance status = 3.0 x 109/l and platelets >= 100 x 109/l [8.] Bilirubin within the reference laboratory’s normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory’s normal range for patients [9.] Willingness to participate in a telephone-based lifestyle intervention program [10.] Intention of regular follow up visits for the duration of the study [11.] Ability to understand the nature of the study and to give written informed consent 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: [12.] Inflammatory breast cancer [13.] Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study [14.] A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) [15.] Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrhythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication [16.] Any known hypersensitivity against Docetaxel, Epirubicine, Cyclophosphamide, or any other medication included in the study protocol. The contraindication, warning notices and measures of precaution of the products, as notified in the product infroamtion, have to be respected [17.] Use of any investigational agent within 3 weeks prior to inclusion [18.] Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured) [19.] Insulin-requiring diabetes mellitus (non-insulin requiring patients with type 2 diabetes are eligible for the study) [20.] Serious digestive and/or absorptive problems that exclude adherence to the study diet [21.] Self-reported inability to walk at least one kilometre (at any pace) SUCCESS C Trial, Version 1.0, 08.09.2008 Page 59 [22.] Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for exclusion [23.] Psychiatric disorders or conditions that would preclude participation in the study intervention [24.] Patients not sufficiently fluent in German language to understand the nature of this study and any of the interventional measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First primary objective of this study is to compare the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil- Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)- chemotherapy versus 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and to compare the disease free survival after randomisation in patients with vs. without lifestyle intervention.;Secondary Objective: Secondary objectives of this study are to compare the following items in the four regimen arms: - Overall survival time after randomization - Local recurrence free survival - Distant disease free survival - Toxicity and cardiotoxicity - Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQBR23 questionnaire, as well as the other included questionnaires in this study - Incidence of secondary primaries - Body weight at 6, 12, 24, 36, 48 and 60 months compared to baseline - HRQOL at 6, 12, 24, 36, 48 and 60 months compared to baseline - Other medical endpoints such as incidence of diabetes and cardiovascular disease - Fasting biomarkers at 12 months compared to baseline - Compliance with study procedures - Endpoints of adjunct translational research program - Efficacy of the antiemetic therapy;Primary end point(s): Comparison of the disease free survival in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus patients getting 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and comparison of the disease free survival in patients with vs. without lifestyle intervention. | — |
Countries
Germany
Outcome results
None listed