A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2021-02-09

Brief Summary

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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

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Detailed Description

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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

Conditions

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Triple Negative Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

SHR-1210 + Apatinib +Fluzoparib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No