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Breast CancerPhase 2NCT03394287

A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC

A Phase 2 study testing SHR-1210 and Apatinib in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms, Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
SHR-1210 and Apatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
10 Jan 2018to 30 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients signed the written informed consent
  • Women aged 18-70.
  • The pathologic diagnosis of recurrent metastatic triple negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
  • At least one measuring lesion that conforms to RECIST v1.1 standard.
  • The number of chemotherapy lines in the metastatic phase was <3 line.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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  • Have a life expectancy of at least 12 weeks.
  • Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
  • The patients can swallow pills.
  • The results of patients' blood tests are as follows: • Hb≥90g/L; • Plt≥90E+9/L; • Neutrophils≥1.5E+9/L; • ALT and AST ≤ triple of normal upper limit; • TBIL ≤ 1.5 times of normal upper limit; • Creatinine ≤ 1.5 times of normal upper limit.

Who cannot join

  • The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
  • Subjects with severe allergic reactions to other monoclonal antibodies.
  • The subjects had a central nervous system metastases with clinical symptoms.
  • History of hypertension and antihypertensive medications are not well controlled.
  • A heart condition or disease that is not well controlled.
  • Subjects had active infections or recent treatment with a systemic immunostimulatory agent (received within the previous 4 weeks).
  • Other clinical trials of drugs were used in the first four weeks of the first medication.
  • Subjects with treatment history of anti-angiogenesis drugs or check-point inhibitors.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: A Phase II, Open-labeled, Randomised, Non-comparative, Two-arms Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib in Subjects With Advanced Triple Negative Breast Cancer

This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms, Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Subjects with advanced Triple Negative Breast Cancer will be recruited. Patients will be randomised to two treatment arms of this study. One arm is SHR-1210 combination with apatinib daily dosing, and the other arm is SHR-1210 combination with apatinib intermittent dosing; each arm will enrolle10-29 subjects (Simons two stage design).

This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in the treatment of advanced TNBC.

Conditions
Breast Cancer
Being tested
SHR-1210, Apatinib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

  • ApatinibDrug

    Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.

Study groups in NCT03394287
Study groupRoleWhat they receive
SHR-1210 +Apatinib daily dosingExperimentalSHR-1210 200mg(3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, daily dosing (d1-d14)
Receives: Drug: SHR-1210; Drug: Apatinib
SHR-1210+Apatinib intermittent dosingExperimentalSHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, intermittent dosing(Continuous administration for 7 days every 14 days, d1-d7)
Receives: Drug: SHR-1210; Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Overall Response Rate

    Measured: from the first drug administration up to the first occurrence of progression or death(up to 24 months)

Secondary outcomes (8)

  1. Incidence of Treatment-Emergent Adverse Events

    adverse events/serious adverse events

    Measured: from the first drug administration to within 90 days for the last SHR-1210 dose

  2. DCR

    Disease Control Rate

    Measured: from the first drug administration up to the first occurrence of progression or death(up to 24 months)

  3. DoR

    Duration of response

    Measured: from the first drug administration up to the first occurrence of progression or death(up to 24 months)

  4. PFS

    Progression-Free-Survival

    Measured: from the first drug administration up to the first occurrence of progression or death (up to about 5 years)

  5. One year-OS

    One year-Overall survival

    Measured: 12 months after the first drug administration

  6. CBR

    Clinical benefit rate

    Measured: from the first drug administration up to the first occurrence of progression or death(up to 24 months)

  7. TTR

    Time to response

    Measured: from the first drug administration up to one year

  8. Frequencies Of Biomarkers

    Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood

    Measured: pre-dose, and up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2018
  2. Study start10 Jan 2018
  3. Primary completion30 Dec 2019
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03394287
Sponsor's protocol ID
SHR-1210-APTN-IIT-TNBC
Status last verified
Oct 2020
First submitted
2 Jan 2018
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu J, Liu Q, Li Y, Li Q, Su F, Yao H, Su S, Wang Q, Jin L, Wang Y, Lau WY, Jiang Z, Song E. Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase II trial. J Immunother Cancer. 2020 May;8(1):e000696. doi: 10.1136/jitc-2020-000696.

    PubMed 32448804

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 and Apatinib in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03394287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

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