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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01997333
Eligibility Criteria:
Inclusion Criteria:
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC
* minimal or no expression of estrogen and progesterone receptors (ER/PR) \<10% of cells positive by immunohistochemistry
* HER 2 staining 0 or 1+ by IHC or copy number \<4.0 signals/cell
2. Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
4. Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
6. ECOG performance status of 0 - 1.
7. Adequate bone marrow, liver and renal function.
Exclusion:
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
1. Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
3. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
4. Significant cardiovascular disease.
5. Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
6. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
7. Chronic use of systemic corticosteroids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01997333
Study Brief:
Protocol Section:
NCT01997333