NCT06786026 QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC
| NCT ID | NCT06786026 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | TNBC, Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2025-09-30 |
Trial Parameters
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Brief Summary
This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily join this study and sign the informed consent form; 2. Female patients aged ≥18 years and ≤70 years old who had been dignosed with breast cancer; 3. According to the definition of the latest ASCO/CAP guidelines, histologically confirmed estrogen receptor negative (ER-) and progesterone receptor negative (PR-), human epidermal growth factor receptor 2 negative 4. For patients with locally advanced, recurrent or metastatic breast cancer who have not used any systematic treatment (it is allowed to accept adjuvant/neoadjuvant treatment, and the time from the last administration to recurrence and metastasis should be ≥ 6 months); 5. According to RECIST 1.1, there is at least one measurable lesion; 6. ECOG score: 0\~1; 7. Tumor tissue specimens that can be used for biomarker detection; 8. Adequate organ function (no blood components or cell growth factor drugs are allowed within 14 days before the first medication): (1) Absolute neutrophil count ≥1.5×109/L;
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