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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
  Purpose

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.


Condition Intervention Phase
HER2+ Metastatic Breast Cancer (MBC)
Drug: neratinib
Drug: capecitabine
Drug: lapatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 600
Study Start Date: March 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neratinib plus capecitabine 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
Active Comparator: lapatinib plus capecitabine 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808573

Contacts
Contact: Puma Biotechnology Clinical Operations 424-248-6500 clinicaltrials@pumabiotechnology.com

  Show 202 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01808573     History of Changes
Other Study ID Numbers: PUMA-NER-1301, 2012-004492-38, UTN U1111-1161-1603
Study First Received: March 4, 2013
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Lapatinib
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014