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

Conditions

• HER2+ Metastatic Breast Cancer (MBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• neratinib — DRUG
• capecitabine — DRUG
• lapatinib — DRUG

Study Details

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.

Key Dates

Start date

Mar 29, 2013

Status verified

May 2021

Primary completion

Sep 28, 2018

Completion

Dec 9, 2019

Study Design

Enrollment

621 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: neratinib plus capecitabine
  neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
• Active Comparator: lapatinib plus capecitabine
  lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.

Primary Outcome Measure

Centrally Assessed Progression Free Survival [ Time Frame: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut. ]

Locations (79)

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