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:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT00453635
Eligibility Criteria:
Inclusion Criteria:
* Performance status (WHO) 0-2
* Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
* HER-2 overexpression 2+ or 3+ using IHC or FISH +
* Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
* No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
* More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
* No prior first line chemotherapy for metastatic disease
* Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
* Paraffin block from the primary tumor available in the research lab
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
* Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
* Adequate cardiac function (LVEF \> 50%)
* Informed consent
Exclusion Criteria:
* Pregnant or nursing
* Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
* Positive pregnancy test
* Motor or sensory neuropathy \> grade 1 according to NCIC Τoxicity Criteria
* Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
* History of allergic reaction attributed to docetaxel
* Psychiatric illness or social situation that would preclude study compliance
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00453635
Study Brief:
Protocol Section:
NCT00453635