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

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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001143

Enrollment

Registered

2014-06-27

Start date

2014-02-27

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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/m2 daily, 750 mg/m2 twice daily [BID]) Arm B: la

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Aged =18 years at signing of informed consent. - Histologically confirmed metastatic breast cancer(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. Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.

Exclusion criteria

Exclusion criteria: Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor. Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Design outcomes

Primary

Measure	Time frame
Independently assessed Progression Free Survival	—

Secondary

Measure	Time frame
Investigator Assessed Progression Free Survival;Objective Response Rate (ORR);Clinical Benefit Rate (CBR) defined as Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for = 24 weeks;Duration of Response (DOR);Time to intervention for symptomatic metastatic central nervous system disease;Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]);Health Outcomes Assessments [Quality of Life Questionnaires; EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L]	—

Measure

Time frame

Investigator Assessed Progression Free Survival;Objective Response Rate (ORR);Clinical Benefit Rate (CBR) defined as Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for = 24 weeks;Duration of Response (DOR);Time to intervention for symptomatic metastatic central nervous system disease;Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]);Health Outcomes Assessments [Quality of Life Questionnaires; EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L]

—

Countries

Korea, Republic of

Contacts

Public ContactAhYoung Eun

Asan Medical Center

Outcome results