A clinical trial to study the effect of HKI-272 in subjects with Advanced breast cancer
- Conditions
- Health Condition 1: null- Breast Neoplasms, Neoplasms
- Registration Number
- CTRI/2009/091/000817
- Lead Sponsor
- Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 137
1.Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
2.Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
3.Over-expression of HER2
4.Tumor tissue available and adequate for analysis at screening
5.At least one measurable lesion
Note: There is no upper age limit criteria mentioned in the protocol
1.Prior treatment with Herceptin (Arm B only)
2.More than 4 prior cytotoxic chemotherapy regimens
3.Subjects with bone or skin as the only site of measurable disease
4.Inadequate cardiac function
5.Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
6.Active central nervous system metastases
7.Pregnant or breastfeeding women
8.Inability to swallow the HKI-272 capsules
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 16 week progression-free survival (PFS) rate of neratinib in women with Her2+ b.c., either with prior Herceptin or no prior Herceptin therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.Timepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method