A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Trial ID or NCT#



not recruiting iconNOT RECRUITING


The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

Official Title

A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Inclusion criteria for both parts of clinical trial: - Good performance status - Normal ejection fraction - Adequate cardiac, kidney, and liver function - Adequate blood counts - At least one measurable target lesion - Negative pregnancy test for female subjects Inclusion Criteria for Part 1 Only: - Pathologically confirmed solid tumor not curable with available standard therapy Inclusion Criteria for Part 2 Only: - Pathologically confirmed breast cancer - HER2 positive tumor - Prior treatment with Herceptin
Exclusion Criteria:
  1. Exclusion criteria for both parts of clinical trial: - Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1 - Subjects with bone or skin as the only site of disease - Active central nervous system metastases - Significant cardiac disease or dysfunction - Significant gastrointestinal disorder - Inability or unwillingness to swallow HKI-272 capsules - Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2. - Treatment with a taxane within 3 months of treatment day 1 - Grade 2 or greater motor or sensory neuropathy - Pregnant or breast feeding women - Known hypersensitivity to paclitaxel or Cremophor EL - Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2 - Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin Exclusion Criteria for Part 2 Only: - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease


George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

Contact us to find out if this trial is right for you.


Mary Chen