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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

Trial Status: Complete

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.

Inclusion Criteria

  • Aged ≥18 years at signing of informed consent.
  • Histologically confirmed MBC, current stage IV.
  • Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
  • Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion Criteria

  • Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: COMPLETED
Los Angeles
Translational Research In Oncology - US Inc
Status: ACTIVE
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: COMPLETED

Hawaii

Honolulu
University of Hawaii Cancer Center
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: COMPLETED
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Towson
UM Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: COMPLETED

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
San Antonio
University of Texas Health Science Center at San Antonio
Status: COMPLETED

Singapore

Singapore
Johns Hopkins Singapore
Status: ACTIVE

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: - Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2 twice daily [BID]) - Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) 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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Puma Biotechnology, Inc.

  • Primary ID PUMA-NER-1301
  • Secondary IDs NCI-2013-01418, 2012-004492-38, UTN U1111-1161-1603, S13-00715
  • Clinicaltrials.gov ID NCT01808573