Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer - Full Text View

Sponsor:	Pfizer
Collaborator:	Puma Biotechnology
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00777101

Purpose

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 II

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Lapatinib Lapatinib Ditosylate HKI-272

U.S. FDA Resources

Further study details as provided by Pfizer:

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:	June 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Neratinib	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777101

Show 200 Study Locations

Sponsors and Collaborators

Pfizer

Puma Biotechnology

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00777101 History of Changes
Other Study ID Numbers:	3144A2-3003, B1891003
Study First Received:	October 21, 2008
Last Updated:	February 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

HER2
ErbB2
metastatic
neratinib
lapatinib

capecitabine
HKI-272
Tykerb
Tyverb
Xeloda

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012