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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01268150
Eligibility Criteria:
Key Inclusion Criteria
Females age 18 years or older at the time of informed consent
Have histologically or cytologically proven adenocarcinoma of the breast
Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors
(RECIST) criteria v 1.1
Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.
Life expectancy of greater than 24 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions
Adequate renal function
Adequate bone marrow function
Adequate liver function
Key Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from participation in this study:
Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer
Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer
Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin
Inflammatory breast cancer
Clinically significant cardiovascular impairment
Subjects with known CNS disease are not eligible, except for those with treated brain metastasis.
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
Currently pregnant or breast-feeding.
Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01268150
Study Brief:
Protocol Section:
NCT01268150