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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)

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ClinicalTrials.gov Identifier: NCT01808573
Recruitment Status : Active, not recruiting
First Posted : March 11, 2013
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
HER2+ Metastatic Breast Cancer (MBC) Drug: neratinib Drug: capecitabine Drug: lapatinib Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 621 participants
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
Actual Study Start Date : March 29, 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Drug: neratinib
Other Name: Nerlynx

Drug: capecitabine
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.
Drug: capecitabine
Other Name: Xeloda

Drug: lapatinib
Other Names:
  • Tykerb
  • Tyverb




Primary Outcome Measures :
  1. Independently assessed Progression Free Survival [ Time Frame: Estimated 10 months ]
  2. Overall Survival [ Time Frame: Estimated 28 months ]

Secondary Outcome Measures :
  1. Investigator Assessed Progression Free Survival [ Time Frame: Estimated 10 months ]
  2. Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ]
  3. 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.

  4. Duration of Response (DOR) [ Time Frame: Estimated 10 months ]
  5. Time to intervention for symptomatic metastatic central nervous system disease [ Time Frame: Estimated 10 months ]
  6. Safety (Adverse Events and Serious Adverse Events) [ Time Frame: From consent through 30 days following treatment completion (estimated 11 months) ]
  7. Health Outcomes Assessments [ Time Frame: Estimated 10 months ]
    Validated Quality of Life Questionnaires


Other Outcome Measures:
  1. Population pharmacokinetics [ Time Frame: 1 month following enrollment ]
    Variability of neratinib concentration when administered in combination with capecitabine among individuals in the target population.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 3+ or 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.


Information from the National Library of Medicine

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


  Show 270 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Clinical Development Senior Vice President Puma Biotechnology, Inc.

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01808573     History of Changes
Other Study ID Numbers: PUMA-NER-1301
2012-004492-38 ( EudraCT Number )
UTN U1111-1161-1603 ( Other Identifier: WHO )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Puma Biotechnology, Inc.:
Neratinib
Nerlynx

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors