A randomized open-label, phase II study of lapatinib/capecitabine or lapatinib/vinorelbine or lapatinib/gemcitabine in subjects with Her2/neu amplified metastatic breast cancer patients progressing after taxanes treatment.
Type of Study: Clinical Trial
Sponsor / Support: LACOG, GAICO, GECOPERU, GSK, Novartis
Primary Objectives: To evaluate Clinical benefit rate (CBR) and safety profile of 2 experimental Lapatinib-chemotherapy combination regimens , Lapatinib- vinorelbine and Lapatinib -gemcitabine as well as the standard lapatinib capecitabine combination after taxanes progression in ErbB2+ metastatic breast Cancer patients.
Design: This is a phase II, open-label, multicentric, international, randomized trial of lapatinb/capecitabine (control arm), lapatinib/vinorelbina (experimental) and lapatinib/gemcitabine (experimental) in ErbB2+ advanced or metastatic breast cancer patients that had progressed to taxanes.
Sample Size: 142 patients
Principal Investigator: Henry Gomez, Carlos Barrios
Countries LATAM: Brazil, Argentina and Peru
Ongoing studies
Breast
GBECAM 0115 – AMAZONA III
LACOG 0413 – Male Breast Cancer
LACOG 0419 – NEOSAMBA
LACOG 0615 – LATINABreast
LACOG 0715 – PALLAS
LACOG 2118 – ALEXANDRA/IMpassion 030
Gastrointestinal
LACOG/GTG 1318 – CCA
LACOG 0119
Gynecological
LACOG 0215 – EVITA
LACOG 0920 – Senticol III
LACOG 1018 – PALBO in Ovarian Cancer
Genitourinary
LACOG 0217 – IRONMAN
LACOG 0218 – Hercules
LACOG 0415 – APA in Prostate Cancer
LACOG 0515 – Testicular Registry
LACOG 0519 – PEACE III
LACOG 0620 – ExBAT
LACOG 1518 – Bladder Cancer Registry
LACOG 1818 – Prostate Cancer Registry
Head and Neck
LACOG 0318 – Induction
LACOG 0319
Lung
LACOG 0116 – LATINO LUNG
LACOG 0118 – RELANCE
LACOG 0417 – CNS MTX
LACOG 0618
LACOG 0718 – PCI Project
LACOG 1918
LACOG 2218 – PACIFIC BRAZIL
Neuro
LACOG 0619