AzTrials
AzTrials

Breast CancerPhase 2NCT04303741

A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC

A Phase 2 study testing Camrelizumab, Apatinib and Eribulin in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a phase II, open-labeled, multi-centered,single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) and eribulin mesylate in patients with advanced triple-negative breast cancer. We will enroll 46 subjects (Simons two stage design). 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?
Camrelizumab, Apatinib and Eribulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
3 sitesChina
Study dates
25 Mar 2020to 31 Aug 2023
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 sign the written informed consent.
  • Women aged 18-70.
  • The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
  • Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
  • The patient can swallow pills.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Show all 10Show fewer
  • With a life expectancy of at least 12 weeks.
  • The results of patient's blood tests are as follows:
  • Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL;• Neutrophils≥1.5^9/L; TSH≤ normal upper limit (ULN);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN); • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);• AKP≤ 2.5 ULN; • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.

Who cannot join

  • The subjects had a central nervous system metastases with clinical symptoms.
  • Other clinical trials of drugs were used in the first four weeks before the first dose.
  • Subjects with severe allergic reactions to other monoclonal antibodies.
  • Received other anti-tumor treatments within 28 days before the first dose.
  • A heart condition or disease that is not well controlled.
  • Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
Show all 13Show fewer
  • The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
  • Subjects had history of hypertension and poor control with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
  • Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity ≥ 1.0g.
  • Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
  • Congenital or acquired immune deficiency (such as HIV infection);
  • Receive live vaccine within 4 weeks before or during the study period;
  • Patients who are allergic to or contraindicated to the experimental drugs.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

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

    Guangzhou, Guangdong, 510120

  • Changhai Hospital, Navy Medical University (Second Military Medical University)

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: An Open-labeled, Single-arm, Investigator-initiated Phase II Trial of Camrelizumab (Anti-PD-1 Antibody) in Combination With Apatinib and Eribulin in Patients With Advanced Triple-Negative Breast Cancer

This is a phase II, open-labeled, multi-centered,single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) and eribulin mesylate in patients with advanced triple-negative breast cancer. We will enroll 46 subjects (Simons two stage design). This study aims to evaluate the efficacy and safety of camrelizumab combined with apatinib and eribulin in the treatment of advanced TNBC.

Read the detailed description

This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with apatinib and eribulin in female patients age of 18 to 70 with advanced TNBC, and previously treated with at least one line of systemic therapy in the advanced setting. Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and a taxane. The number of patients to be included is 46 patients (Simons two stage design). The primary objective is to assess the overall response rate (ORR). All enrolled patients will be treated with camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 21-day cycle, and apatinib 250mg daily (po, d1-d21), in combination with eribulin mesylate at 1.4 mg/m2 (iv.) on day 1 and day 8 of every 21-day cycle.

Conditions
Breast Cancer
Being tested
Camrelizumab, Apatinib, Eribulin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.

  • ApatinibDrug

    Apatinib 250mg will be administered daily until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.

  • EribulinDrug

    Also called Eribulin Mesylate

    Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.

Study groups in NCT04303741
Study groupRoleWhat they receive
Camrelizumab +Apatinib+EribulinExperimentalCamrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv Q3W combination with Apatinib 250mg, po, daily (d1-d21)and Eribulin1.4mg/m2 iv d1, d8 Q3W
Receives: Drug: Camrelizumab; Drug: Apatinib; Drug: Eribulin

What is being measured

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

  1. Overall response rate (ORR)

    The propotion of subjects with CR or PR.

    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 dose

  2. Disease Control Rate (DCR)

    The propotion of subjects with CR, PR, or SD.

    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 24 months)

  5. One year-OS rate

    One year-Overall survival rate

    Measured: 12 months after the first drug administration

  6. Clinical benefit rate (CBR)

    The propotion of subjects with CR, PR, or SD for >=6 months during the study.

    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 (including tumor/stromal PD-L1, stromal PD-1, tumor-infiltrating lymphocytes and tumor-infiltrating B cells, eg)

    Measured: pre-treatment, up to 24 months

Timeline

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

  1. First posted11 Mar 2020
  2. Study start25 Mar 2020
  3. Primary completion30 Nov 2022
  4. Study completion31 Aug 2023 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303741
Sponsor's protocol ID
Immuno2020-01
Status last verified
Apr 2023
First submitted
7 Mar 2020
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu J, Wang Y, Tian Z, Lin Y, Li H, Zhu Z, Liu Q, Su S, Zeng Y, Jia W, Yang Y, Xu S, Yao H, Jiang W, Song E. Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nat Commun. 2022 May 31;13(1):3011. doi: 10.1038/s41467-022-30569-0.

    PubMed 35641481

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Apatinib and Eribulin in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites 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 13 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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?

Overall response rate (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 NCT04303741, 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 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in