A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)
A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to one of the following treatment arms:
Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
Inclusion Criteria:
Exclusion Criteria:
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Bakersfield, California 93309, United States
La Jolla, California 92093-0698, United States
San Diego, California 92103, United States
Baltimore, Maryland 21231, United States
Lutherville, Maryland 21093, United States
Towson, Maryland 21204, United States
Salvador, Estado de Bahia 41950-610, Brazil
Caxias do Sul, Rio Grande do Sul 95070-560, Brazil
Ribeirão Preto, São Paulo 14015-130, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Abbotsford British Columbia, British Columbia V2S 0C2, Canada
Québec, Quebec G1S 4L8, Canada
Pierre-Bénite, Lyon 69495, France
Cologne, 50931, Germany
Kitaadachi-gun, Saitama 362-0806, Japan
Gunma, 371-8511, Japan
Hokkaido, 003-0804, Japan
Ôsaka, 540-0006, Japan
Moscow, Moscow 129301, Russia
Moscow, 115478, Russia
Girona, 17007, Spain
Las Palmas de Gran Canaria, 35016, Spain
Madrid, 28041, Spain