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Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777101
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : November 9, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Description
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Brief Summary:
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Breast Cancer Drug: Neratinib Drug: Lapatinib Drug: Capecitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer
Actual Study Start Date : February 4, 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neratinib Drug: Neratinib
Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
Other Name: HKI-272
Active Comparator: Lapatinib plus Capecitabine Drug: Lapatinib
Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
Other Name: Tykerb, Tyverb

Drug: Capecitabine
Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
Other Name: Xeloda


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: From randomization date to progression or death, assessed up to 69 months ]
    Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization date to death, assessed up to 69 months ]
    Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.

  2. Objective Response Rate (ORR). [ Time Frame: From randomization date to progression or last tumor assessment, assessed up to 69 months ]
    Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.

  3. Clinical Benefit Rate [ Time Frame: From randomization date to progression or last tumor assessment, assessed up to 69 months ]

    Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Clinical Benefit (CB) = CR + PR + SD >= 24 weeks.


  4. Duration of Response [ Time Frame: From start date of response to first PD, assessed up to 69 months after the first subject was randomized. ]
    Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

  5. Frequency of CNS Metastases (Frequency) [ Time Frame: From randomization date to first CNS symptom or lesions ]
    The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.

  6. Time to CNS Metastases [ Time Frame: From randomization date to first CNS symptom or lesions ]
    Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  • Prior use of Herceptin (trastuzumab), and a taxane
  • Adequate cardiac and renal function

Exclusion Criteria:

  • More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  • Bone as the only site of disease
  • Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  • Significant gastrointestinal disorder with diarrhea as major symptom
Contacts and Locations
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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): NCT00777101


Locations
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Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
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Study Director: Puma Biotechnology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00777101    
Other Study ID Numbers: 3144A2-3003 / B1891003
First Posted: October 22, 2008    Key Record Dates
Results First Posted: November 9, 2017
Last Update Posted: August 9, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Puma Biotechnology, Inc.:
HER2
ErbB2
metastatic
neratinib
lapatinib
 capecitabine
HKI-272
Nerlynx
PB-272
Additional relevant MeSH terms:
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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