Spots Global Cancer Trial Database for Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
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Trial Identification
Brief Title: Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
Official Title: Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
Study ID: NCT01049425
Study Description
Brief Summary: The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Bethesda Krankenhaus, Moenchengladbach, , Germany
Contact Details
Name: Ulrike A. Nitz, Prof. Dr. med.
Affiliation: Ev. Krankenhaus Bethesda Moenchengladbach
Role: PRINCIPAL_INVESTIGATOR
Name: Nadia Harbeck, Prof. Dr. med.
Affiliation: University Hospital Cologne
Role: STUDY_CHAIR
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