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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Advanced Breast Cancer, Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

16 Weeks

Safety Issue:

No

Principal Investigator

Puma

Investigator Role:

Study Director

Investigator Affiliation:

Biotechnology

Authority:

United States: Food and Drug Administration

Study ID:

3144A2-3003

NCT ID:

NCT00777101

Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Advanced Breast Cancer
  • Breast Cancer
  • HER2
  • ErbB2
  • metastatic
  • neratinib
  • lapatinib
  • capecitabine
  • HKI-272
  • Tykerb
  • Tyverb
  • Xeloda
  • Breast Neoplasms

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654