TNBC - Triple-Negative Breast CancerPhase 2NCT05402722
Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
A Phase 2 study testing Eribulin and anti-PD-1 antibody in people with TNBC - Triple-Negative Breast Cancer, run by Beijing 302 Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Eribulin and anti-PD-1 antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients sign the written informed consent.
- Women aged 18-75.
- 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.
- PD-1/PD-L1positive or TMB≥5.
- Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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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.
Who cannot join
- The subjects had a central nervous system metastases with clinical symptoms.
- Subjects with treatment history of PD-1 / PD-L1 inhibitors;
- Peripheral neuropathy ≥ grade 2; Cardiac dysfunction, hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis and tuberculosis; Autoimmune diseases requiring systemic treatment, and a history of pneumonia (requiring corticosteroid treatment) or interstitial lung disease.
- Pregnant or lactating women.
- Other clinical trials of drugs were used in the first four weeks before the first dose.
- The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
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- 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.
- Other malignant tumors in the past, except cervical cancer and non melanoma skin cancer, which have survived for 5 years without disease.
- Subjects with any other diseases that are unfit for the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Tao Wang, +86-010-66947172, wangtaotg@163.com
About this study
Official title: A Phase II Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Eribulin, anti-PD-1 antibody
- Keywords
- TNBC, Eribulin, anti-PD-1 antibody
- 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.
EribulinDrug
Also called Halaven
Eribulin Mesylate，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
anti-PD-1 antibodyDrug
Sintilimab Injection，Intravenous infusion，200mg，3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Eribulin in combination with anti-PD-1 antibody | Experimental | Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) . Receives: Drug: Eribulin; Drug: anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival，PFS
The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Secondary outcomes (2)
Number of participants with Adverse Events
Adverse Events are monitored throughout the trial and for 30 days after discontinuation of treatment (90 days for serious adverse events) and graded according to the Common Terminology Criteria for Adverse Events, version 4.0, of the National Cancer Institute.
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
the correlation between the expression of PD-L1 of circulating tumor cells and prognosis
To detect the differences of the expression of PD-L1 in patients with different curative effects and prognosis,including the number of circulating tumor cells,and PD-L1 expression or others.
Measured: From one week before treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402722
- Sponsor's protocol ID
- breast-202204
- Status last verified
- Jan 2022
- First submitted
- 13 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05402722
- Acronym / sponsor ID
- breast-202204
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- TNBC, Eribulin, anti-PD-1 antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin in combination with anti-PD-1 antibody | Experimental | Drug: Eribulin, Drug: anti-PD-1 antibodyParticipants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patients sign the written informed consent.
- Women aged 18-75.
- 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.
- PD-1/PD-L1positive or TMB≥5.
- Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
Key exclusion criteria (12 listed)
- The subjects had a central nervous system metastases with clinical symptoms.
- Subjects with treatment history of PD-1 / PD-L1 inhibitors;
- Peripheral neuropathy ≥ grade 2; Cardiac dysfunction, hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis and tuberculosis; Autoimmune diseases requiring systemic treatment, and a history of pneumonia (requiring corticosteroid treatment) or interstitial lung disease.
- Pregnant or lactating women.
- Other clinical trials of drugs were used in the first four weeks before the first dose.
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 |
|---|---|---|
| EribulinAlso: HalavenEribulin Mesylate，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle | Drug | Eribulin in combination with anti-PD-1 antibody |
| anti-PD-1 antibodySintilimab Injection，Intravenous infusion，200mg，3-week cycle | Drug | Eribulin in combination with anti-PD-1 antibody |
Primary outcome
Progression Free Survival，PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.
2 secondary outcomes
Number of participants with Adverse Events
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
the correlation between the expression of PD-L1 of circulating tumor cells and prognosis
Time frame: From one week before treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin and anti-PD-1 antibody in people with TNBC - Triple-Negative Breast Cancer, run by Beijing 302 Hospital 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 12 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 2 Jun 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 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?
Contact xiaobo wang, doctor (+86-010-66947250, 724292466@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival，PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 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 2 Jun 2022.