Clinical trial · Interventional
First-line Nab-paclitaxel Plus Cisplatin Plus Camrelizumab in mTNBC Patients
A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Camrelizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
NCT04537286CI-TRIAL-00118787completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel plus cisplatin plus Camrelizumab (AP+PD-1)
- description
- Nab-paclitaxel 125 mg/m2,ivgtt,d1, 8 Cisplatin 75 mg/m2,ivgtt,d1 Camrelizumab 200mg, ivgtt,d1,q3w
- interventionNames
- Drug: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
Primary outcomes (2)
- measure
- PFS
- timeFrame
- 6 weeks
- description
- Progression free survival
- measure
- Adverse events
- timeFrame
- 6 weeks
- description
- Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged 18-70 years who had 2. Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures. 3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer. 4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment. 5. At least one measurable lesion according to RECIST 1.1, 6. ECOG performance status ≤ 1 7. Life expectancy of more than 12 weeks 8. Adequate organ and bone marrow function. Exclusion Criteria: 1. Patient of childbearing potential but unwilling to receive contraception. 2. Radiation therapy of axial bone within 4 weeks before enrollment. 3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody. 4. Patients have active autoimmune diseases. 5. Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period. 6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted) 7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted) 8. Uncontrolled infection.
References
Publications (0)
Data not yet available
No reference posted for this study.