Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

August 10, 2018 updated by: Puma Biotechnology, Inc.

Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet Unite du Chimiotherapie
      • Leuven, Belgium, 3000
        • University Hospital Gasthuisberg
      • Wilrijk, Belgium, 2610
        • St-Augustinus Ziekenhuis Oncology Department
  • China
      • Beijing, China, 100853
        • Chinese People's Liberation Army General Hospital
      • Beijing, China, 100021
        • Cancer Hospital Peking Union Medical College
    • Beijing
      • Beijing, Beijing, China, 100071
        • The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • No. 81 Hospital of Chinese People's Liberation Army
  • France
      • Villejuif Cedex, France, 94805
        • Institut Gustave ROUSSY Service de Pathologie Mammaire
  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital
      • Pune, Maharashtra, India, 411001
        • Jehangir Clinical Development Centre
    • Panjagutta
      • Hyderabad, Panjagutta, India, 50082
        • Nizam's Institute of Medical Sciences
    • Parel
      • Mumbai, Parel, India, 400012
        • Tata Memorial Centre
  • Mexico
      • Mexico City, Mexico, 06700
        • ARKE Estudios Clínicos S.A. de C.V.
      • Mexico City, Mexico, 01030
        • Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica
      • Mexico City, Mexico, 07300
        • Hospital de Especialidades MIG
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin Russian Cancer Research Center of RAMS
      • Obninsk, Russian Federation, 249036
        • Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods
      • Saint Petersburg, Russian Federation, 197022
        • City Oncology Dispensary
      • Saint Petersburg, Russian Federation, 197110
        • City Hospital N 31 Oncology Haematology Dept. For Adults
      • Saint-Petersburg, Russian Federation, 197758
        • Breast Tumor Department, N.N. Petrov Research Institute of Oncology
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Illinois
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • The Cancer Center at GBMC
      • Bethesda, Maryland, United States, 20817
        • Oncology Care Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
      • Boston, Massachusetts, United States, 02130
        • Faulkner Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • The Cancer Institute of New Jersey
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Taussig Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
  • Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
  • Over-expression of HER2
  • Tumor tissue available and adequate for analysis at screening
  • At least one measurable lesion

Exclusion Criteria:

  • Prior treatment with Herceptin (Arm B only)
  • More than 4 prior cytotoxic chemotherapy regimens
  • Subjects with bone or skin as the only site of measurable disease
  • Inadequate cardiac function
  • Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
  • Active central nervous system metastases
  • Pregnant or breastfeeding women
  • Inability to swallow the HKI-272 capsules

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neratinib 240 mg, with prior trastuzumab
Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
Drug: neratinib
Other Names:
  • HKI-272
  • Nerlynx
Experimental: Neratinib 240 mg, no prior trastuzumab
Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
Drug: neratinib
Other Names:
  • HKI-272
  • Nerlynx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16-week Progression Free Survival
Time Frame: From first dose to 16 weeks
16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
From first dose to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: From first dose date to progression or last tumor assessment, up to 46 months
Percentage of participants with Partial Response (PR) or Complete Response (CR) by independent assessment of tumor per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From first dose date to progression or last tumor assessment, up to 46 months
Clinical Benefit Rate
Time Frame: From first dose date to progression or last tumor assessment, up to 46 months
Percentage of participants who experienced Complete Response (CR), Partial Response (PR), or Stable Disease (SD) ≥ 24 weeks by independent assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
From first dose date to progression or last tumor assessment, up to 46 months
Duration of Response
Time Frame: From start date of response to first PD/death, up to 46 months
Number of weeks between Complete Response (CR) or Partial Response (PR) and the first date of disease progression (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
From start date of response to first PD/death, up to 46 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 7, 2006

First Posted (Estimate)

March 9, 2006

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3144A1-201 / B1891012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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