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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Puma Biotechnology, Inc. Identifier:
First received: October 21, 2008
Last updated: April 28, 2015
Last verified: April 2015
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 Intervention Phase
Advanced Breast Cancer
Breast Cancer
Drug: Neratinib
Drug: Lapatinib
Drug: Capecitabine
Phase 2

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 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Common Terminology Criteria for Adverse Events [CTCAE] V3 [ Time Frame: Subject's duration on active portion of the study. ] [ Designated as safety issue: Yes ]
  • Clinical benefit rate, objective response rate, duration of response [ Time Frame: subject's duration ] [ Designated as safety issue: No ]
  • Frequency of and time to central nervous system metastases [ Time Frame: subject's duration ] [ Designated as safety issue: No ]
  • Population PK [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: February 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: Neratinib
Tablets, 240mg once per day until disease progression or unacceptable toxicity
Other Name: HKI-272
Active Comparator: B
Lapatinib plus Capecitabine
Drug: Lapatinib
Tablets 1250mg once per day until disease progression or unacceptable toxicity.
Other Name: Tykerb, Tyverb
Drug: Capecitabine
Tablets 2000mg/m2 given 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


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

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
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 identifier: NCT00777101

  Show 200 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00777101     History of Changes
Other Study ID Numbers: 3144A2-3003  B1891003 
Study First Received: October 21, 2008
Last Updated: April 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 26, 2016