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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03945604

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted March 19, 2020

Study Description

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

  • Condition or Disease:Triple Negative Breast Cancer
  • Intervention/Treatment: Drug: SHR-1210 + Apatinib +Fluzoparib
  • Phase: Phase 1
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 aptinib and fluzoparib

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 52 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: August 2021
Arms and interventions
Arm Intervention/treatment
Experimental: 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
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.
Outcome Measures
  • Primary Outcome Measures: 1. Dose Limiting Toxicity (DLT) [ Time Frame: First cycle (28 days) ]
    Dose Limiting Toxicity
  • Secondary Outcome Measures: 1. Adverse Events and Serious Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose ]
    AEs and SAEs
  • 2. Overall Response Rate (ORR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  • 3. Duration of response (DoR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  • 4. Disease Control Rate [ Time Frame: up to 12 months (approx) from the start of treatment ]
    DCR
  • 5. Progression-Free-Survival [ Time Frame: up to 12 months (approx) from the start of treatment ]
    PFS
  • 6. 12-months overall survival rate [ Time Frame: From the start of treatment to 1 year ]
    12-months overall survival rate
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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 comfirmed 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.

Contacts and Locations
Contacts

Contact: Zongfei Zongfei Dai, master 18616240775 zongfeidai@hrglobe.cn

Contact: Quanren Wang, PhD 18036618570 wangquanren@hrglobe.cn

Locations

China, Beijing
Beijing Cancer Hosptial
Beijing

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

Principal Investigator: Huiping Li, PhD Beijing Cancer Hosptial

More Information
  • Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03945604 History of Changes
  • Other Study ID Numbers: FZPL-Ib-105
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: March 19, 2020
  • Last Verified: June 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms Triple Negative Breast Neoplasms