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A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer


Inclusion Criteria:



- Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.

- Been treated for early breast cancer with standard of care duration of trastuzumab.

- Could have been treated neoadjuvantly but have not reached pCR.

Exclusion Criteria:

- Positive clinical and radiologic assessments for local or regional recurrence of
disease at the time of study entry.

- History of heart disease.

- QTc interval >0.45 seconds

- History of gastrointestinal disease with diarrhea as the major symptom.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

disease free survival (DFS)

Outcome Time Frame:

Two years

Safety Issue:

No

Principal Investigator

Puma

Investigator Role:

Study Director

Investigator Affiliation:

Biotechnology

Authority:

United States: Food and Drug Administration

Study ID:

3144A2-3004

NCT ID:

NCT00878709

Start Date:

July 2009

Completion Date:

October 2013

Related Keywords:

  • Breast Cancer
  • HER-2/erbB-2 positive breast cancer
  • breast cancer
  • adjuvant therapy
  • neratinib
  • HKI-272
  • Breast Neoplasms

Name

Location
Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
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 Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site North Little Rock, Arkansas  72117
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site North Adams, Massachusetts  01247
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 Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Livingston, New Jersey  07039
Pfizer Investigational Site Washington, District of Columbia  20007-2197
Pfizer Investigational Site Burlington, Vermont  05401-3456
Pfizer Investigational Site Salt Lake City, Utah  84112
Pfizer Investigational Site Billings, Montana  59101
Pfizer Investigational Site Lewistown, Idaho  83501
Pfizer Investigational Site Bangor, Maine  04401
Pfizer Investigational Site Honolulu, Hawaii  96813
Pfizer Investigational Site Bismarck, North Dakota  58503
Pfizer Investigational Site Aberdeen, South Dakota  57401
Pfizer Investigational Site Morgantown, West Virginia  26506
Pfizer Investigational Site Providence, Rhode Island  02906