Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment.

PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

September 30, 2011

Conditions
BRMS1Performance Status Zero to Two for Beginning the StudyPatient With a Maximum of One ChemotherapyPatient With Progression After Taxanes
Interventions
DRUG

Lapatinib Vinorelbine

The starting dose of vinorelbine is 25 mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.

DRUG

Lapatinib Capecitabine

The starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.

DRUG

Gemcitabine Lapatinib

The starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.

Trial Locations (18)

17210120

Dr. Gustavo Ismael, Jaú

Unknown

Dr. Guillermo Lerzo, Buenos Aires

Dr. Eduardo Richardet, Córdoba

Dr. Adolfo Capó, Mendoza

Dr. Juan Lacava, Neuquén

Dra. Mirta Varela, Quilmes

Dr. Luis Fein, Rosario

Dr. Jose Zarba, San Miguel de Tucumán

Dr. Cesar Blajman, Santa Fe

Dra. Silvia Neciosup, Lima

41950-610

Dr. Carlos Alberto Sampaio, Salvador

20560-120

Dr. José Bines, Rio de Janeiro

90610-000

Dr. Carlos Barrios, Porto Alegre

88034-000

Dra. Yeni Veronica Neron, Florianópolis

09060-870

Dra. Patricia Xavier Santi, Santo André

01246-000

Dr. Max Mano, São Paulo

01509-900

Dr. Marcello Fanelli, São Paulo

03102-002

Dra. Célia Tosselo de Oliveira, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER

NCT01050322 - Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment. | Biotech Hunter | Biotech Hunter