Clinical trial · Interventional
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
A Phase Ib，Open-labeled, Multi-center, Dose-exploring Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib and Fluzoparib in Subjects With Recurrent and Metastatic Triple Negative Breast Cancer
NCT03945604CI-TRIAL-00060302completedPhase 1ClinicalTrials.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)
The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1210 + Apatinib +Fluzoparib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1210 + Apatinib +Fluzoparib
- description
- SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity
- interventionNames
- Drug: SHR-1210 + Apatinib +Fluzoparib
Primary outcomes (1)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- First cycle (28 days)
- description
- Dose Limiting Toxicity
Secondary outcomes (6)
- measure
- Adverse Events and Serious Adverse Events
- timeFrame
- from the first drug administration to within 90 days for the last SHR-1210 dose
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Signed the informed consent. * Female aged ≥18 years old. * Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer. * No more than 2-line chemotherapy failed at the stage of recurrence and metastasis . * Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment * At least one measuring lesion that confirmed by RECIST v1.1 standard. * The patients can swallow pills. * Have a life expectancy of at least 12 weeks. * The functions of vital organs meet protocal requirements. Exclusion Criteria: * Subjects had any history of active autoimmune disease . * Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors. * Subjects have untreated central nervous system metastasis. * History of hypertension and antihypertensive medications are not well controlled. * Some clinical symptoms or diseases of the heart that are not well controlled. * History of immunodeficiency including HIV-positive. * Subjects had active infections.
References
Publications (1)
- DERIVEDZhang Q, Shao B, Tong Z, Ouyang Q, Wang Y, Xu G, Li S, Li H. A phase Ib study of camrelizumab in combination with apatinib and fuzuloparib in patients with recurrent or metastatic triple-negative breast cancer. BMC Med. 2022 Oct 3;20(1):321. doi: 10.1186/s12916-022-02527-6. PMID 36184642