Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00398567
Eligibility Criteria:
Inclusion Criteria:
* Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy
* Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
* HER2 positive breast cancer
* At least one measurable target lesion
* Adequate performance status
* Adequate cardiac, kidney, and liver function
* Adequate blood counts
* Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control
Exclusion Criteria:
* More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
* Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1
* Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2
* Extensive visceral disease
* Active central nervous system metastases
* Pregnant or breast feeding women
* Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
* Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)
* Significant cardiac disease or dysfunction
* History of life-threatening hypersensitivity to Herceptin
* Inability or unwillingness to swallow HKI-272 capsules
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00398567
Study Brief:
Protocol Section:
NCT00398567