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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 Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Livingston, New Jersey  07039
Pfizer Investigational Site Salt Lake City, Utah  84112
Pfizer Investigational Site Morgantown, West Virginia  26506
Pfizer Investigational Site Providence, Rhode Island  02906