Trial Condition(s):

Breast Neoplasms, Breast Cancer, Metastatic

Safety and efficacy study of a new chemotherapy agent to treat metastatic breast cancer

Bayer Identifier:

91464

ClinicalTrials.gov Identifier:

NCT00288249

EudraCT Number:

2005-003216-30

Study Completed

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

Inclusion Criteria
- Metastatic breast cancer
 - No previous treatment with taxanes, and vinca alkaloids
 - Use of highly effective birth control methods in females of child-bearing potential
Exclusion Criteria
- More than 2 previous chemotherapies
 - Previous participation in another trial within the last 4 weeks
 - Breast feeding
 - Active infections

Trial Summary

Enrollment Goal
82
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Centre Paul Papin

Angers, France, 49033

Status
Completed
 
Locations

Centre Jean Perrin Clermont Ferrand

Clermont Ferrand, France, 63011

Status
Completed
 
Locations

Klinicni center

Ljubljana, Slovenia, 1000

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

SMZ Süd- Kaiser- Franz- Josef- Spital

Wien, Austria, 1100

Status
Completed
 
Locations

District Dispensary for Oncology Diseases with Inpatient

Sofia, Bulgaria, 01784

Status
Completed
 
Locations

Dr. Antoaneta Tomova

Plovdiv, Bulgaria, 4001

Status
Completed
 
Locations

Oncology Dispencery Varna

Varna, Bulgaria, 9000

Status
Completed
 
Locations

Centre Gauducheau

Saint Herblain Cedex, France, 44805

Status
Completed
 
Locations

Institut Bergonie

Bordeaux, France, 33076

Status
Completed
 
Locations

Centre Alexis Vautrin

Vandoeuvre les Nancy, France, 54500

Status
Completed
 
Locations

Universitätsklinikum Charite zu Berlin

Berlin, Germany, 10117

Status
Completed
 
Locations

P.O. Morgagni-Pierantoni

Forlì, Italy, 47100

Status
Completed
 
Locations

A.O. S.Maria Nuova

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Ospedale Niguarda Ca' Granda

Milano, Italy, 20162

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Completed
 
Locations

AZ Klina

BRASSCHAAT, Belgium, 2930

Status
Completed
 
Locations

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

Status
Completed
 
Locations

ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, Poland, 10-228

Status
Completed
 

Trial Design