Breast CancerPhase 3NCT04335006
A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.
A Phase 3 study testing Carelizumab, Nab-paclitaxel and Apatinib in people with Breast Cancer and Triple Negative Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Carelizumab, Nab-paclitaxel and Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2020to 14 Apr 2023
- Phase
- Phase 3
- 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
- ECOG Performance Status of 0-1.
- Expected lifetime of not less than three months
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection.
- No prior systemic antitumor therapy for metastatic triple-negative breast cancer.
- Adequate hematologic and organ function
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Who cannot join
- Known central nervous system (CNS) disease.
- Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody.
- A history of bleeding, any serious bleeding events.
- Uncontrolled pleural effusion, pericardial effusion.
- Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
- History of interstitial pneumonitis.
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- Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc.
- Prior allogeneic stem cell or solid organ transplantation.
- History of autoimmune disease
- Active hepatitis B or hepatitis C
- Pregnancy or lactation.
- Peripheral neuropathy grade ≥2.
- Participants with poor blood pressure control;
- Myocardial infarction incident within 6 months prior to randomisation;
- Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
- Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: A Multicentre, Open-parallel, Randomized, Controlled Phase Ⅲ Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer.
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Carelizumab, Nab-paclitaxel, Apatinib
- Keywords
- SHR-1210, PD-1
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarelizumabDrug
Also called SHR-1210
Participants receive SHR-1210 intravenously (IV)
Nab-paclitaxelDrug
administered intravenously every 4-week cycle
ApatinibDrug
administered orally every 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Experimental A | Experimental | Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle Receives: Drug: Carelizumab; Drug: Nab-paclitaxel; Drug: Apatinib |
| Experimental B | Experimental | Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle Receives: Drug: Carelizumab; Drug: Nab-paclitaxel |
| Comparator C | Active comparator | Subjects receive nab-paclitaxel intravenously each 4-week cycle. Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression-free survival (PFS) as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in PD-L1 positive / ITT population
Measured: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)
Secondary outcomes (7)
Progression Free Survival (PFS)
Progression Free Survival (PFS) as determined by the investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in PD-L1 positive/ITT population
Measured: Up to approximately 42 months
Overall Survival (OS) in PD-L1 positive/ITT population
Measured: Up to approximately 42 months
Objective response rate (ORR) in the PD-L1-positive/ITT population
Measured: Up to approximately 42 months
Clinical benefit rate (CBR), defined as the proportion of patients with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1
Measured: Up to approximately 42 months
Percentage of Participants with Adverse Events (AEs)
Measured: Up to approximately 42 months
Serum concentration of SHR-1210 and plasma concentration of apatinib
Measured: Up to approximately 42 months
Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Measured: Up to approximately 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start14 Jul 2020
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335006
- Sponsor's protocol ID
- SHR-1210-III-318
- Status last verified
- May 2023
- First submitted
- 31 Mar 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-parallel, Randomized, Controlled Phase Ⅲ Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT04335006
- Acronym / sponsor ID
- SHR-1210-III-318
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- SHR-1210, PD-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 6 Apr 2020 (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.
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental A | Experimental | Drug: Carelizumab, Drug: Nab-paclitaxel, Drug: ApatinibSubjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle |
| Experimental B | Experimental | Drug: Carelizumab, Drug: Nab-paclitaxelSubjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle |
| Comparator C | Active comparator | Drug: Nab-paclitaxelSubjects receive nab-paclitaxel intravenously each 4-week cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG Performance Status of 0-1.
- Expected lifetime of not less than three months
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection.
- No prior systemic antitumor therapy for metastatic triple-negative breast cancer.
Key exclusion criteria (16 listed)
- Known central nervous system (CNS) disease.
- Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody.
- A history of bleeding, any serious bleeding events.
- Uncontrolled pleural effusion, pericardial effusion.
- Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
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 |
|---|---|---|
| CarelizumabAlso: SHR-1210Participants receive SHR-1210 intravenously (IV) | Drug | Experimental A, Experimental B |
| Nab-paclitaxeladministered intravenously every 4-week cycle | Drug | Comparator C, Experimental A, Experimental B |
| Apatinibadministered orally every 4-week cycle | Drug | Experimental A |
Primary outcome
Progression-free Survival (PFS)
Time frame: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)
Progression-free survival (PFS) as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in PD-L1 positive / ITT population
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to approximately 42 months
Overall Survival (OS) in PD-L1 positive/ITT population
Time frame: Up to approximately 42 months
Objective response rate (ORR) in the PD-L1-positive/ITT population
Time frame: Up to approximately 42 months
Clinical benefit rate (CBR), defined as the proportion of patients with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1
Time frame: Up to approximately 42 months
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 42 months
Serum concentration of SHR-1210 and plasma concentration of apatinib
Time frame: Up to approximately 42 months
Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Time frame: Up to approximately 42 months
Results and safety
The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carelizumab, Nab-paclitaxel and Apatinib in people with Breast Cancer and 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 May 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.
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?
Progression-free Survival (PFS) (time frame: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.