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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01038804
Eligibility Criteria:
Inclusion Criteria:
* Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
* No prior chemotherapy regimen for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
* The subject's life expectancy is estimated to be \> 12 weeks at the Baseline Visit
* The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
Exclusion Criteria:
* Hypersensitivity to docetaxel or polysorbate 80
* Neuropathy ≥ Grade 2 at the Baseline Visit
* Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
* The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01038804
Study Brief:
Protocol Section:
NCT01038804