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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT01156961
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Locally recurrent or metastatic Her2-negative breast cancer
* Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of \>/=12 months is required
* Adequate haematological, renal and liver function
Exclusion Criteria:
* Previous chemotherapy for locally recurrent or metastatic disease
* Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of \</= 30% of marrow-bearing bone)
* CNS metastases
* Pre-existing peripheral neuropathy
* Clinically significant cardiovascular disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01156961
Study Brief:
Protocol Section:
NCT01156961