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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01611727
Eligibility Criteria:
Inclusion Criteria:
* Female patients aged ≥ 18 years, with measurable (defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14)) metastatic (stage IV) breast cancer, and who are known to carry a BRCA1 mutation, are eligible.
* In addition, the following are required:
* adequate hematologic
* renal, and hepatic function
* adequate recovery from recent surgery and/or radiation therapy
* recovery from all prior treatment-related toxicities (to grade \< 2 according to National Cancer Institute Common Toxicity Criteria, Version3.0, except alopecia)
* life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. -
* Patients could have received up to four prior chemotherapies for metastatic disease.
Exclusion Criteria:
* Patients with known brain metastases are not eligible.
* Patients previously treated with a platinum-based chemotherapy are not eligible.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01611727
Study Brief:
Protocol Section:
NCT01611727