check_circleStudy Completed
Breast Neoplasms, Breast Cancer
Bayer Identifier:
100555
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY43-9006 - Phase II in Advanced Breast Cancer
Trial purpose
The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.
Key Participants Requirements
Sex
FemaleAge
18 YearsTrial summary
Enrollment Goal
54Trial Dates
February 2004 - January 2008Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Frauenklinik vom Roten Kreuz | München, 80637, Germany |
Completed | IRCCS Istituto Nazionale Tumori | Milano, 20133, Italy |
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60590, Germany |
Completed | A.O. Osp Niguarda Ca' Granda | Milano, 20162, Italy |
Completed | Marienhospital | Stuttgart, 70199, Germany |
Completed | A.O.U. di Bologna | Bologna, 40138, Italy |
Completed | A.O.U. di Parma | Parma, 43100, Italy |
Primary Outcome
- Number of Subjects With Response (Complete or Partial)date_rangeTime Frame:Until 30 days after termination of active therapyenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to Progressiondate_rangeTime Frame:Until progression occursenhanced_encryptionNoSafety Issue:
- Time to Objective Responsedate_rangeTime Frame:Until objective response occursenhanced_encryptionNoSafety Issue:
- Overall Response Durationdate_rangeTime Frame:Time from PR or CR to progressionenhanced_encryptionNoSafety Issue:
- Survival Timedate_rangeTime Frame:Start of treatment to deathenhanced_encryptionNoSafety Issue:
- Number of Subjects With Stable Disease up to Cycle 4date_rangeTime Frame:Until 30 days after termination of active therapyenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1