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

Study ID
PUMA-NER-1301

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Contact
Sarah Weyandt
214/648-7020
sarah.weyandt@utsouthwestern.edu

Principal Investigator
Barbara Haley

Official Title

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

Brief Overview


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.

Summary


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.

Participant Eligibility


Inclusion Criteria:

- Aged ≥18 years at signing of informed consent.

- Histologically confirmed MBC, current stage IV.

- Documented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+
or IHC 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.

Note: There are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.