At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 189 enrolled
Drug / intervention
Epirubicin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
"A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"
In Brief
A Phase 2 clinical trial evaluating Epirubicin, Cyclophosphamide, and 4 other interventions for Breast Cancer. Completed, enrolled 189 participants across 12 sites.
Detailed Summary
This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesSpain
CollaboratorsPfizer
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartApr 2007
Primary CompletionSep 2010
TodayJul 2026
First PostedFeb 7, 2007
Enrollment StartApr 24, 2007
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.4 years ago
Interventions
Epirubicindrug
Cyclophosphamidedrug
Docetaxeldrug
Exemestanedrug
Goserelindrug
Carboplatindrug