Simultaneous Study of Docetaxel Based Anthracycline FreeAdjuvant Treatment Evaluation, as well as Life Style InterventionStrategiesSUCCESS C-Trial - Success-C

Phase 1

• Conditions: Patients with primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, pM0; MedDRA version: 19.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 100000004864

• Registration Number: EUCTR2008-005453-38-DE
• Lead Sponsor: niversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-20
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 3547

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: ‘pT2,
histopathological grade 3, age <= 35, negative hormone receptor’
[4.] Complete resection of the primary tumor with margins of resection free of
invasive carcinoma not more than 6 weeks ago
[5.] Females >=18 years of age
[6.] Performance status <= 2 on ECOG-Scale
[7.] Adequate bone marrow reserve: leucocytes >= 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

[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

Study & Design

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