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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02144194
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Patients \>=18 years of age
* Histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
* Measurable and/or non-measurable disease
* The patient's primary and/or metastatic tumor is HER2 neu negative
* Documented metastatic disease previously untreated with palliative chemotherapy
* Adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
* No symptom or sign of brain metastasis
Exclusion Criteria:
* Operable local recurrence
* Ascites or pericardial effusion as only site of metastasis
* Symptomatic peripheral neuropathy \> grade 1 according to the NCI Common Toxicity Criteria
* Radiotherapy to all areas of evaluable disease within the previous 4 weeks
* Disease significantly affecting absorption
* Severe hepatic insufficiency
* Patient previously treated with chemotherapy for their metastatic disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02144194
Study Brief:
Protocol Section:
NCT02144194