A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC
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ClinicalTrials.gov Identifier: NCT04303741 |
Recruitment Status :
Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : April 12, 2023
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Camrelizumab Drug: Apatinib Drug: Eribulin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 25, 2020 |
Actual Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | August 31, 2023 |
Arm | Intervention/treatment |
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Experimental: Camrelizumab +Apatinib+Eribulin
Camrelizumab 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
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Drug: Camrelizumab
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. Drug: Apatinib 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. Drug: Eribulin 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.
Other Name: Eribulin Mesylate |
- Overall response rate (ORR) [ Time Frame: from the first drug administration up to the first occurrence of progression or death (up to 24 months) ]The propotion of subjects with CR or PR.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last dose ]Adverse events/serious adverse events
- Disease Control Rate (DCR) [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]The propotion of subjects with CR, PR, or SD.
- DOR [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]Duration of response
- PFS [ Time Frame: from the first drug administration up to the first occurrence of progression or death (up to 24 months) ]Progression-Free-Survival
- One year-OS rate [ Time Frame: 12 months after the first drug administration ]One year-Overall survival rate
- Clinical benefit rate (CBR) [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]The propotion of subjects with CR, PR, or SD for >=6 months during the study.
- TTR [ Time Frame: from the first drug administration up to one year ]Time to response
- Frequencies of Biomarkers [ Time Frame: pre-treatment, up to 24 months ]Biomarkers (including tumor/stromal PD-L1, stromal PD-1, tumor-infiltrating lymphocytes and tumor-infiltrating B cells, eg)
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- With a life expectancy of at least 12 weeks.
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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.
Exclusion Criteria:
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303741
China, Guangdong | |
The First Affiliated Hospital, Sun Yat-Sen University | |
Guangzhou, Guangdong, China, 510000 | |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |
Guangzhou, Guangdong, China, 510120 | |
China, Shanghai | |
Changhai Hospital, Navy Medical University (Second Military Medical University) | |
Shanghai, Shanghai, China, 200433 |
Principal Investigator: | Jieqiong Liu | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
Responsible Party: | Jieqiong Liu, M.D., Ph.D., Associate Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
ClinicalTrials.gov Identifier: | NCT04303741 |
Other Study ID Numbers: |
Immuno2020-01 |
First Posted: | March 11, 2020 Key Record Dates |
Last Update Posted: | April 12, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Apatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |