Clinical trial NCT03945604: A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Triple Negative Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Drug: SHR-1210 + Apatinib +Fluzoparib 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.

Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib

Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: First cycle (28 days)
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: from the first drug administration to within 90 days for the last SHR-1210 dose
measure: Overall Response Rate (ORR)
timeFrame: up to 12 months (approx) from the start of treatment
measure: Duration of response (DoR)
timeFrame: up to 12 months (approx) from the start of treatment
measure: Disease Control Rate
timeFrame: up to 12 months (approx) from the start of treatment
measure: Progression-Free-Survival
timeFrame: up to 12 months (approx) from the start of treatment
measure: 12-months overall survival rate
timeFrame: From the start of treatment to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hosptial
state: Beijing
Study officials:
affiliation: Beijing Cancer Hosptial
name: Huiping Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang 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.