Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

March 31, 2008

Study Completion Date

January 31, 2009

Conditions
Breast NeoplasmsBreast Cancer, Metastatic
Interventions
DRUG

Sagopilone (BAY86-5302, ZK 219477)

16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

DRUG

Sagopilone (BAY86-5302, ZK 219477)

12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

DRUG

Sagopilone (BAY86-5302, ZK 219477)

22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

DRUG

Sagopilone (BAY86-5302, ZK 219477)

22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Trial Locations (21)

1000

Ljubljana

1090

Vienna

1100

Vienna

2930

Brasschaat

4001

Plovdiv

9000

Varna

10117

Berlin

20162

Milan

28040

Madrid

29010

Málaga

33076

Bordeaux

42100

Reggio Emilia

44805

Saint-Herblain

47100

Forlì

49033

Angers

54500

Vandœuvre-lès-Nancy

63011

Clermont-Ferrand

01784

Sofia

10-228

Olsztyn

02-781

Warsaw

M20 4BX

Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY