check_circleStudy Completed
Breast Neoplasms, Breast Cancer, Metastatic
Bayer Identifier:
91464
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Safety and efficacy study of a new chemotherapy agent to treat metastatic breast cancer
Trial purpose
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
82Trial Dates
December 2005 - January 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Sagopilone (BAY86-5302)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | Centre Paul Papin | Angers, 49033, France |
Completed | Centre Jean Perrin Clermont Ferrand | Clermont Ferrand, 63011, France |
Completed | Klinicni center | Ljubljana, 1000, Slovenia |
Completed | Christie Hospital | Manchester, M20 4BX, United Kingdom |
Completed | SMZ Süd- Kaiser- Franz- Josef- Spital | Wien, 1100, Austria |
Completed | District Dispensary for Oncology Diseases with Inpatient | Sofia, 01784, Bulgaria |
Completed | Dr. Antoaneta Tomova | Plovdiv, 4001, Bulgaria |
Completed | Oncology Dispencery Varna | Varna, 9000, Bulgaria |
Completed | Centre Gauducheau | Saint Herblain Cedex, 44805, France |
Completed | Institut Bergonie | Bordeaux, 33076, France |
Completed | Centre Alexis Vautrin | Vandoeuvre les Nancy, 54500, France |
Completed | Universitätsklinikum Charite zu Berlin | Berlin, 10117, Germany |
Completed | P.O. Morgagni-Pierantoni | Forlì, 47100, Italy |
Completed | A.O. S.Maria Nuova | Reggio Emilia, 42100, Italy |
Completed | Ospedale Niguarda Ca' Granda | Milano, 20162, Italy |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Hospital Virgen de la Victoria | Málaga, 29010, Spain |
Completed | AZ Klina | BRASSCHAAT, 2930, Belgium |
Completed | Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie | Warszawa, 02-781, Poland |
Completed | ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii | Olsztyn, 10-228, Poland |
Primary Outcome
- Tumor response rate (complete or partial response according to RECIST)The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).date_rangeTime Frame:Every 6 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Duration of complete or partial tumor responseDefined as the time between the first date that confirmed complete or partial response was established as “overall response” and the first date that recurrence or overall response of progressive disease was documenteddate_rangeTime Frame:Every 6 weeksenhanced_encryptionnoSafety Issue:
- Time to tumor progressionDefined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancerdate_rangeTime Frame:Every 6 weeksenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
4