NCT00300781

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_2

Geographic Reach
7 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

August 4, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

March 7, 2006

Results QC Date

August 10, 2017

Last Update Submit

August 10, 2018

Conditions

Breast NeoplasmsNeoplasms

Keywords

phase 2HER2+ breast cancermonotherapy neratinibHKI-272NeratinibNerlynxPB-272

Outcome Measures

Primary Outcomes (1)

  • 16-week Progression Free Survival

    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 Outcomes (3)

  • Objective Response Rate

    From first dose date to progression or last tumor assessment, up to 46 months

  • Clinical Benefit Rate

    From first dose date to progression or last tumor assessment, up to 46 months

  • Duration of Response

    From start date of response to first PD/death, up to 46 months

Study Arms (2)

Neratinib 240 mg, with prior trastuzumab

EXPERIMENTAL

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

Neratinib 240 mg, no prior trastuzumab

EXPERIMENTAL

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

Interventions

neratinibDRUG
Also known as: Nerlynx, HKI-272
Neratinib 240 mg, no prior trastuzumabNeratinib 240 mg, with prior trastuzumab

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Louisiana State University

Shreveport, Louisiana, 71103, United States

Location

The Cancer Center at GBMC

Baltimore, Maryland, 21204, United States

Location

Oncology Care Associates

Bethesda, Maryland, 20817, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

The Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Institut Jules Bordet Unite du Chimiotherapie

Brussels, 1000, Belgium

Location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

St-Augustinus Ziekenhuis Oncology Department

Wilrijk, 2610, Belgium

Location

The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

Location

No. 81 Hospital of Chinese People's Liberation Army

Nanjing, Jiangsu, 210002, China

Location

Cancer Hospital Peking Union Medical College

Beijing, 100021, China

Location

Chinese People's Liberation Army General Hospital

Beijing, 100853, China

Location

Institut Gustave ROUSSY Service de Pathologie Mammaire

Villejuif, 94805, France

Location

Jehangir Clinical Development Centre

Pune, Maharashtra, 411001, India

Location

Deenanath Mangeshkar Hospital

Pune, Maharashtra, 411004, India

Location

Nizam's Institute of Medical Sciences

Hyderabad, Panjagutta, 50082, India

Location

Tata Memorial Centre

Mumbai, Parel, 400012, India

Location

Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica

Mexico City, 01030, Mexico

Location

Arke Estudios Clínicos S.A. de C.V.

Mexico City, 06700, Mexico

Location

Hospital de Especialidades MIG

Mexico City, 07300, Mexico

Location

N.N. Blokhin Russian Cancer Research Center of RAMS

Moscow, 115478, Russia

Location

Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods

Obninsk, 249036, Russia

Location

City Oncology Dispensary

Saint Petersburg, 197022, Russia

Location

City Hospital N 31 Oncology Haematology Dept. For Adults

Saint Petersburg, 197110, Russia

Location

Breast Tumor Department, N.N. Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

neratinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Senior Director, Clinical Operations
Organization
Puma Biotechnology, Inc.
clinicaltrials@pumabiotechnology.com
+1 (424) 248-6500

Study Officials

  • Puma

    Biotechnology

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

August 4, 2006

Primary Completion

April 1, 2008

Study Completion

January 30, 2018

Last Updated

August 14, 2018

Results First Posted

September 13, 2017

Record last verified: 2018-08

Locations

IN(4)RU(5)ME(3)US(13)CN(4)BE(3)FR(1)