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A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer


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

Thank you

Trial Information

A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer


Inclusion Criteria:



- ErbB-2 positive locally recurrent or metastatic breast cancer

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Measurable disease

- Availability of tumor tissue for HER2 status confirmation

Exclusion Criteria:

- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
or metastatic disease

- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
adjuvant setting

- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
therapy

- history of heart disease

- history of gastrointestinal disease

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:

31 months

Safety Issue:

No

Principal Investigator

Puma

Investigator Role:

Study Director

Investigator Affiliation:

Biotechnology

Authority:

United States: Food and Drug Administration

Study ID:

3144A2-3005

NCT ID:

NCT00915018

Start Date:

August 2009

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • Advanced Breast Cancer
  • Breast Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteMorgantown, West Virginia  26506
Pfizer Investigational SiteProvidence, Rhode Island  02906