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)
|HER2+ Metastatic Breast Cancer (MBC)||Drug: neratinib Drug: capecitabine Drug: lapatinib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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 [AEs] and Serious Adverse Events [SAEs]) [ 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; EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L
- Population pharmacokinetics [ Time Frame: 1 month following enrollment ]To assess the variability of neratinib concentration when administered in combination with capecitabine among individuals in the target population.
|Actual Study Start Date:||March 29, 2013|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
|Experimental: neratinib plus capecitabine||
240 mg orally, once daily with food, continuously in 21 day cyclesDrug: 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: Xeloda
|Active Comparator: lapatinib plus capecitabine||
1250 mg orally, once daily, continuously in 21 day cycles
Other Names:Drug: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808573
|Contact: Puma Biotechnology Clinical Operationsfirstname.lastname@example.org|
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