Triple Negative Breast CancerPhase 1NCT03945604
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
A Phase 1 study testing SHR-1210 + Apatinib +Fluzoparib in people with Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- SHR-1210 + Apatinib +Fluzoparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2019to 9 Feb 2021
- Phase
- Phase 1
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- The patients can swallow pills.
- Have a life expectancy of at least 12 weeks.
- The functions of vital organs meet protocal requirements.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Triple Negative Breast Cancer
- Being tested
- SHR-1210 + Apatinib +Fluzoparib
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210 + Apatinib +FluzoparibDrug
Also called Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and 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.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 + Apatinib +Fluzoparib | Experimental | 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 Receives: Drug: SHR-1210 + Apatinib +Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Dose Limiting Toxicity
Measured: First cycle (28 days)
Secondary outcomes (6)
Adverse Events and Serious Adverse Events
AEs and SAEs
Measured: from the first drug administration to within 90 days for the last SHR-1210 dose
Overall Response Rate (ORR)
Measured: up to 12 months (approx) from the start of treatment
Duration of response (DoR)
Measured: up to 12 months (approx) from the start of treatment
Disease Control Rate
DCR
Measured: up to 12 months (approx) from the start of treatment
Progression-Free-Survival
PFS
Measured: up to 12 months (approx) from the start of treatment
12-months overall survival rate
12-months overall survival rate
Measured: From the start of treatment to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start4 Jun 2019
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiping Li, PhD, Principal investigator, Beijing Cancer Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945604
- Sponsor's protocol ID
- FZPL-Ib-105
- Status last verified
- Aug 2022
- First submitted
- 9 May 2019
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36184642
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03945604
- Acronym / sponsor ID
- FZPL-Ib-105
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1210 + Apatinib +Fluzoparib | Experimental | Drug: SHR-1210 + Apatinib +FluzoparibSHR-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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1210 + Apatinib +FluzoparibAlso: Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparibSHR-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 |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: First cycle (28 days)
Dose Limiting Toxicity
6 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
Overall Response Rate (ORR)
Time frame: up to 12 months (approx) from the start of treatment
Duration of response (DoR)
Time frame: up to 12 months (approx) from the start of treatment
Disease Control Rate
Time frame: up to 12 months (approx) from the start of treatment
Progression-Free-Survival
Time frame: up to 12 months (approx) from the start of treatment
12-months overall survival rate
Time frame: From the start of treatment to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Derived from this study: PubMed 36184642Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiping Li, PhD principal investigator
Beijing Cancer Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1210 + Apatinib +Fluzoparib in people with Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 9 inclusion and 7 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 12 Aug 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Dose Limiting Toxicity (DLT) (time frame: First cycle (28 days)). 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 NCT03945604, 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 12 Aug 2022.