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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07359404
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged \> 18 years.
2. Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC).
3. ER and PR negativity is defined as \< 10% expression in tumor cells. HER2 negativity is defined as IHC 0, 1+, or IHC 2+ with FISH negative. Must have received at least one prior systemic therapy in the metastatic setting.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy of more than 3 months.
6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
7. Adequate organ function.
8. Sufficient washout period before screening (3 weeks from last chemotherapy, 4 weeks from last targeted therapy)
Exclusion Criteria:
1. Prior treatment with Sacituzumab Govitecan or Bevacizumab.
2. Uncontrolled central nerve
3. Presence of other primary malignancies.
4. Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07359404
Study Brief:
Protocol Section:
NCT07359404