Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
- Registration Number
- NCT00300781
- Lead Sponsor
- Puma Biotechnology, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 136
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neratinib 240 mg, with prior trastuzumab neratinib 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 240 mg, no prior trastuzumab neratinib 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.
- Primary Outcome Measures
Name Time Method 16-week Progression Free Survival 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate 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.
Duration of Response 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
Clinical Benefit Rate 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.
Trial Locations
- Locations (33)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
The Cancer Center at GBMC
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Arke Estudios Clínicos S.A. de C.V.
🇲🇽Mexico City, Mexico
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Oncology Care Associates
🇺🇸Bethesda, Maryland, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
St-Augustinus Ziekenhuis Oncology Department
🇧🇪Wilrijk, Belgium
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
Institut Jules Bordet Unite du Chimiotherapie
🇧🇪Brussels, Belgium
Institut Gustave ROUSSY Service de Pathologie Mammaire
🇫🇷Villejuif Cedex, France
Cancer Hospital Peking Union Medical College
🇨🇳Beijing, China
Deenanath Mangeshkar Hospital
🇮🇳Pune, Maharashtra, India
No. 81 Hospital of Chinese People's Liberation Army
🇨🇳Nanjing, Jiangsu, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Jehangir Clinical Development Centre
🇮🇳Pune, Maharashtra, India
Chinese People's Liberation Army General Hospital
🇨🇳Beijing, China
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, Panjagutta, India
Tata Memorial Centre
🇮🇳Mumbai, Parel, India
Hospital de Especialidades MIG
🇲🇽Mexico City, Mexico
Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica
🇲🇽Mexico City, Mexico
N.N. Blokhin Russian Cancer Research Center of RAMS
🇷🇺Moscow, Russian Federation
Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods
🇷🇺Obninsk, Russian Federation
City Hospital N 31 Oncology Haematology Dept. For Adults
🇷🇺Saint Petersburg, Russian Federation
City Oncology Dispensary
🇷🇺Saint Petersburg, Russian Federation
Breast Tumor Department, N.N. Petrov Research Institute of Oncology
🇷🇺Saint-Petersburg, Russian Federation
Louisiana State University
🇺🇸Shreveport, Louisiana, United States