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Trial record 1 of 1 for:    PUMA-NER-1301
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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Puma Biotechnology, Inc.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01808573
First received: March 4, 2013
Last updated: October 21, 2014
Last verified: September 2014

March 4, 2013
October 21, 2014
March 2013
May 2017   (final data collection date for primary outcome measure)
  • Independently assessed Progression Free Survival [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Estimated 28 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01808573 on ClinicalTrials.gov Archive Site
  • Investigator Assessed Progression Free Survival [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to intervention for symptomatic metastatic central nervous system disease [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From consent through 30 days following treatment completion (estimated 11 months) ] [ Designated as safety issue: Yes ]
  • Health Outcomes Assessments [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
    Validated Quality of Life Questionnaires; EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L
Same as current
Population pharmacokinetics [ Time Frame: 1 month following enrollment ] [ Designated as safety issue: No ]
To assess the variability of neratinib concentration when administered in combination with capecitabine among individuals in the target population.
Same as current
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HER2+ Metastatic Breast Cancer (MBC)
  • Drug: neratinib
    240 mg orally, once daily with food, continuously in 21 day cycles
  • Drug: 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
  • Drug: lapatinib
    1250 mg orally, once daily, continuously in 21 day cycles
    Other Names:
    • Tykerb
    • Tyverb
  • 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
  • Experimental: neratinib plus capecitabine
    Interventions:
    • Drug: neratinib
    • Drug: capecitabine
  • Active Comparator: lapatinib plus capecitabine
    Interventions:
    • Drug: lapatinib
    • Drug: capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
May 2018
May 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged ≥18 years at signing of informed consent.
  • Histologically confirmed 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.

Exclusion Criteria:

  • Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Both
18 Years and older
No
Contact: Puma Biotechnology Clinical Operations 424-248-6500 clinicaltrials@pumabiotechnology.com
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hong Kong,   Israel,   Korea, Republic of,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom
 
NCT01808573
PUMA-NER-1301, 2012-004492-38, UTN U1111-1161-1603
Yes
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Not Provided
Puma Biotechnology, Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP