Clinical trial NCT00300781: Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
Official title: Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Neoplasms
Keywords: phase 2
HER2+ breast cancer
monotherapy neratinib
HKI-272
Neratinib
Nerlynx
PB-272
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-09
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 16-week Progression Free Survival
timeFrame: From first dose to 16 weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From first dose date to progression or last tumor assessment, up to 46 months
measure: Clinical Benefit Rate
timeFrame: From first dose date to progression or last tumor assessment, up to 46 months
measure: Duration of Response
timeFrame: From start date of response to first PD/death, up to 46 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Shreveport
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: The Cancer Center at GBMC
state: Maryland
city: Bethesda
country: United States
facility: Oncology Care Associates
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Cleveland
country: United States
facility: The Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Brussels
country: Belgium
facility: Institut Jules Bordet Unite du Chimiotherapie
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Wilrijk
country: Belgium
facility: St-Augustinus Ziekenhuis Oncology Department
city: Beijing
country: China
facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
state: Beijing
city: Nanjing
country: China
facility: No. 81 Hospital of Chinese People's Liberation Army
state: Jiangsu
city: Beijing
country: China
facility: Cancer Hospital Peking Union Medical College
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Villejuif Cedex
country: France
facility: Institut Gustave ROUSSY Service de Pathologie Mammaire
city: Pune
country: India
facility: Jehangir Clinical Development Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
state: Maharashtra
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
state: Panjagutta
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Parel
city: Mexico City
country: Mexico
facility: Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica
city: Mexico City
country: Mexico
facility: Arke Estudios Clínicos S.A. de C.V.
city: Mexico City
country: Mexico
facility: Hospital de Especialidades MIG
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center of RAMS
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods
city: Saint Petersburg
country: Russian Federation
facility: City Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: City Hospital N 31 Oncology Haematology Dept. For Adults
city: Saint-Petersburg
country: Russian Federation
facility: Breast Tumor Department, N.N. Petrov Research Institute of Oncology
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References: