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)
|ClinicalTrials.gov Identifier: NCT01808573|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2013
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|HER2+ Metastatic Breast Cancer (MBC)||Drug: neratinib Drug: capecitabine Drug: lapatinib||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||621 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 29, 2013|
|Actual Primary Completion Date :||September 28, 2018|
|Estimated Study Completion Date :||March 31, 2020|
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.
Other Name: Nerlynx
Other Name: Xeloda
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.
Other Name: Xeloda
- Independently assessed Progression Free Survival [ Time Frame: Estimated 10 months ]
- Overall Survival [ Time Frame: Estimated 28 months ]
- Investigator Assessed Progression Free Survival [ Time Frame: Estimated 10 months ]
- Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ]
- Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ]CBR is defined as Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 24 weeks.
- Duration of Response (DOR) [ Time Frame: Estimated 10 months ]
- Time to intervention for symptomatic metastatic central nervous system disease [ Time Frame: Estimated 10 months ]
- Safety (Adverse Events and Serious Adverse Events) [ Time Frame: From consent through 30 days following treatment completion (estimated 11 months) ]
- Health Outcomes Assessments [ Time Frame: Estimated 10 months ]Validated Quality of Life Questionnaires
- Population pharmacokinetics [ Time Frame: 1 month following enrollment ]Variability of neratinib concentration when administered in combination with capecitabine among individuals in the target population.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808573
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|Study Director:||Clinical Development Chief Medical and Scientific Officer||Puma Biotechnology, Inc.|