Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
NCT ID: NCT00300781
Last Updated: 2018-08-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2006-08-04
2018-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
NCT00398567
Study Evaluating HKI-272 in Tumors
NCT00146172
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
NCT00445458
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
NCT00741260
Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
NCT00706030
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
neratinib
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.
neratinib
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
neratinib
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Puma Biotechnology, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Puma
Role: STUDY_DIRECTOR
Biotechnology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado Hospital
Aurora, Colorado, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Louisiana State University
Shreveport, Louisiana, United States
The Cancer Center at GBMC
Baltimore, Maryland, United States
Oncology Care Associates
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Faulkner Hospital
Boston, Massachusetts, United States
Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
The Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Institut Jules Bordet Unite du Chimiotherapie
Brussels, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
St-Augustinus Ziekenhuis Oncology Department
Wilrijk, , Belgium
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, Beijing Municipality, China
No. 81 Hospital of Chinese People's Liberation Army
Nanjing, Jiangsu, China
Cancer Hospital Peking Union Medical College
Beijing, , China
Chinese People's Liberation Army General Hospital
Beijing, , China
Institut Gustave ROUSSY Service de Pathologie Mammaire
Villejuif, , France
Jehangir Clinical Development Centre
Pune, Maharashtra, India
Deenanath Mangeshkar Hospital
Pune, Maharashtra, India
Nizam's Institute of Medical Sciences
Hyderabad, Panjagutta, India
Tata Memorial Centre
Mumbai, Parel, India
Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica
Mexico City, , Mexico
Arke Estudios Clínicos S.A. de C.V.
Mexico City, , Mexico
Hospital de Especialidades MIG
Mexico City, , Mexico
N.N. Blokhin Russian Cancer Research Center of RAMS
Moscow, , Russia
Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods
Obninsk, , Russia
City Oncology Dispensary
Saint Petersburg, , Russia
City Hospital N 31 Oncology Haematology Dept. For Adults
Saint Petersburg, , Russia
Breast Tumor Department, N.N. Petrov Research Institute of Oncology
Saint Petersburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3144A1-201 / B1891012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.