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)
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|ClinicalTrials.gov Identifier: NCT01808573|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2013
Last Update Posted : September 4, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|