Breast CancerPhase 2NCT07255612
Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer)
A Phase 2 study testing Trilaciclib and Eribulin in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Triple negative breast cancer (TNBC) has attracted much attention due to its young age of onset, high aggressiveness, lack of clear therapeutic targets and poor clinical prognosis.Eribulin is a novel non-taxane anti-microtubule inhibitor with unique microtubule and non-microtubule anti-tumor mechanism.Myelosuppression… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trilaciclib and Eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2026to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old , no limitation of gender;
- locally advanced or metastatic triple-negative breast cancer;
- have received at least two prior chemotherapy regimens(The recurrence of the last adjuvant chemotherapy is counted one line within 12 months after surgery);
- At least one measurable lesion according to RECIST version 1.1;
- The laboratory tests meet the following criteria:
- Hemoglobin: ≥ 100 g / L (female), 110g / L (male) Neutrophil count : ≥2×10^9/L Platelet count: ≥100×10^9/L Creatinine：≤15mg / L or creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula); Total bilirubin：≤1.5× upper limit of normal (ULN) Alutamate aminotransferase (ALT) and glutamate aminotransferase (AST)≤ 3 ×ULN or 5 ×ULN (for patients with liver metastases) Albumin: ≥ 30 g / L;
Show all 10Show fewer
- Eastern Cooperative Oncology Group (ECOG) score [0-1] points;
- The expected survival period is ≥3 months;
- During the screening period, all female with potential fertility must have negative serum pregnancy tests and reliable contraception after signing the informed consent form until 3 months after the last dose;
- Comprehend and voluntarily sign the informed consent form;
Who cannot join
- Diagnosed other malignant disease besides breast cancerwithin 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection);
- Main organ function not good enough;
- Bone marrow invasion;
- Require combined chemotherapy other than Eribulin;
- Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment;
- QTcF > 480 msec ( screening period) and QTcF> 500 msec for patients with ventricular pacemaker implantation;
Show all 10Show fewer
- Previous hematopoietic stem cell or bone marrow transplantation;
- Previous G-CSF treatment in the last 2 weeks;
- Allergic to the study drug or the ingredients;
- Any other situation where the researcher considers the patient not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Phase II Study for Bone Marrow Protection, Safety, and Efficacy of Trilaciclib Combined With Eribulin in Locally Advanced or Metastatic Triple-negative Breast Cancer After at Least Two Prior Chemotherapy Regimens
Triple negative breast cancer (TNBC) has attracted much attention due to its young age of onset, high aggressiveness, lack of clear therapeutic targets and poor clinical prognosis.Eribulin is a novel non-taxane anti-microtubule inhibitor with unique microtubule and non-microtubule anti-tumor mechanism.Myelosuppression is the cause of many cancer chemotherapy-related adverse events, such as infections, sepsis, bleeding, and fatigue, resulting in delayed hospital stays or the need for treatment with hematopoietic growth factors, blood transfusions, and more.In addition, myelosuppression usually leads to a lower dose or longer interval of chemotherapy, which reduces the intensity of chemotherapy and affects the benefit of chemotherapy for patients.Trilaciclib is a highly potent, selective and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy.
Read the detailed description
Four randomized, double-blind clinical trials of treacilil in patients with small cell lung cancer (SCLC) confirmed that Trilaciclib administration in combination with chemotherapy prevented or mitigated chemotherapy-induced myelosuppression.Among them, the G1T28-05 study showed that the administration of Trilaciclib before first-line chemotherapy (carboplatin combined with etoposide) could reduce the duration of severe neutropenia in the first cycle from 4 days to 0 days, and the incidence of severe neutropenia from 49.1% to 1.9%.As the world's first drug designed to reduce chemotherapy-induced myelosuppression by protecting HSPCs, Trilaciclib has demonstrated a significant ability to prevent chemotherapy-mediated multicellular lineage myelosuppression in patients with ES-SCLC.In February 2021, the U.S. Food and Drug Administration (FDA) approved Trilaciclib (COSELA™) to reduce the incidence of chemotherapy-induced myelodepression in adult patients with extensive stage small cell lung cancer prior to receiving a platinum-containing/etoposide regimen or topotecan regimen.
Based on the evidence that Trilaciclib has been approved by the FDA to reduce the incidence of chemotherapy-induced myelopathic depression in adult patients with extensive stage small cell lung cancer prior to receipt of a platinum-containing/etoposide regimen or topotecan regimen, there is encouraging patient outcome improvement observed in study G1T28-04.This Phase II clinical trial was designed to confirm the bone marrow protection and efficacy and safety of Trilaciclib in patients with locally advanced/metastatic TNBC who had previously received at least two chemotherapy regimes prior to treatment with Eribulin.
- Conditions
- Breast Cancer
- Being tested
- Trilaciclib, 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.
TrilaciclibDrug
Each participant receives Trilaciclib(240mg/m², intravenous infusion for 30 minutes, and completed within 4 hours before chemotherapy administration on day 1 and day 8, day 21 was 1 cycle)
EribulinDrug
Each participant receives Eribulin(1.4mg/m², intravenous infusion at day 1 and day 8, with 1 cycle at day 21)
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib Plus Eribulin | Experimental | Trilaciclib: 240mg/m², intravenous infusion for 30 minutes, and completed within 4 hours before chemotherapy administration on day 1 and day 8, day 21 was 1 cycle; Eribulin: 1.4mg/m², intravenous infusion at day 1 and day 8, with 1 cycle at day 21; Note: Trilaciclib combined with Eribulin was treated for cycles 1-2, and continued use of trilaciclib combined with eribulin was a clinical decision from cycle 3 onwards.The infusion interval between treacilil and subsequent injections should not exceed 4 hours.
Hematopoietic growth factor, blood transfusion, or platelet transfusion are not allowed during the week prior to the blood test during the subject screening period, and no prophylaxis of any cytogenic subclass drugs (including granulocyte colony stimulating factor, granulocyte giant cell colony co-stimulating factor, and erythropoietin) is allowed during the first cycle.However, it can be used therapeutically and should be used in strict accordance with relevant guidelines. Receives: Drug: Trilaciclib; Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of grade 3 neutropenia during cycle 1-2 of chemotherapy treatment
evaluated by CIM related index(Chemotherapy-Induced Myelosuppression) , CTCAE5.0(Common Terminology Criteria for Adverse Events)
Measured: 6 months
Secondary outcomes (7)
Anti-tumor efficacy
Conduct tumor imaging assessments. Baseline imaging examinations should be conducted within 21 days prior to the first dose of study drug, and tumor imaging assessments should be conducted every 6 weeks (±7 days) starting from the first administration of the study drug.
The results of the efficacy evaluations are categorized into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), and unevaluable (NE).
Then calculate the indicators to evaluate the anti-tumor efficacy.
Indicators includes: Objective response rate (ORR),Disease Control Rate( DCR),Duration of response (DOR), Progression free survival (PFS),Overall survival (OS)
Measured: 6 months
Adverse events, abnormal laboratory tests, etal
Adverse events, abnormal laboratory tests, etal; to evaluate safety and tolerability.
Measured: 6 months
Bone marrow protection
Incidence of grade 3 or 4 thrombocytopenia during cycles 1-2; rate of grade 3 or 4 anemia during cycles 1-2; rate of febrile neutropenia; using rate of granulocyte colony-stimulating factor (G-CSF); rate of platelet transfusion; incidence of red cell infusion (week 5 and beyond); using rate of erythropoietin (ESA); using rate of iron; using rate of recombinant human interleukin-11 and / or thrombopoietin (TPO);
Measured: 6 months
Disease burden(cost)
Treatment-related costs of chemotherapy-induced myelosuppression during cycles 1-2 (registration, bed, care, examination / testing and other costs);
Measured: 6 months
Disease burden(in-stay time)
in-stay of myelosuppression caused by chemotherapy
Measured: 6 months
Disease burden(quality of life)
quality of life during chemotherapy (subject EQ-5D-5L, FACT-L and FACT-An scale score)
Measured: 6 months
Compliance with the chemotherapy regimen
Dose of eribulin; The incidence and dose reduction of eribulin chemotherapy during cycles 1-2 of chemotherapy(if there exists dose reduction) ;incidence and duration of delayed changes in chemotherapy(if there exists delayed changes in chemotherapy); and relative dose intensity of eribulin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start4 Nov 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu fei, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255612
- Sponsor's protocol ID
- PROTECTION
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Study for Bone Marrow Protection, Safety, and Efficacy of Trilaciclib Combined With Eribulin in Locally Advanced or Metastatic Triple-negative Breast Cancer After at Least Two Prior Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT07255612
- Acronym / sponsor ID
- PROTECTION
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
Triple negative breast cancer (TNBC) has attracted much attention due to its young age of onset, high aggressiveness, lack of clear therapeutic targets and poor clinical prognosis.Eribulin is a novel non-taxane anti-microtubule inhibitor with unique microtubule and non-microtubule anti-tumor mechanism.Myelosuppression is the cause of many cancer chemotherapy-related adverse events, such as infections, sepsis, bleeding, and fatigue, resulting in delayed hospital stays or the need for treatment with hematopoietic growth factors, blood transfusions, and more.In addition, myelosuppression usually leads to a lower dose or longer interval of chemotherapy, which reduces the intensity of chemotherapy and affects the benefit of chemotherapy for patients.Trilaciclib is a highly potent, selective and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy.
Detailed description
Four randomized, double-blind clinical trials of treacilil in patients with small cell lung cancer (SCLC) confirmed that Trilaciclib administration in combination with chemotherapy prevented or mitigated chemotherapy-induced myelosuppression.Among them, the G1T28-05 study showed that the administration of Trilaciclib before first-line chemotherapy (carboplatin combined with etoposide) could reduce the duration of severe neutropenia in the first cycle from 4 days to 0 days, and the incidence of severe neutropenia from 49.1% to 1.9%.As the world's first drug designed to reduce chemotherapy-induced myelosuppression by protecting HSPCs, Trilaciclib has demonstrated a significant ability to prevent chemotherapy-mediated multicellular lineage myelosuppression in patients with ES-SCLC.In February 2021, the U.S. Food and Drug Administration (FDA) approved Trilaciclib (COSELA™) to reduce the incidence of chemotherapy-induced myelodepression in adult patients with extensive stage small cell lung cancer prior to receiving a platinum-containing/etoposide regimen or topotecan regimen.
Based on the evidence that Trilaciclib has been approved by the FDA to reduce the incidence of chemotherapy-induced myelopathic depression in adult patients with extensive stage small cell lung cancer prior to receipt of a platinum-containing/etoposide regimen or topotecan regimen, there is encouraging patient outcome improvement observed in study G1T28-04.This Phase II clinical trial was designed to confirm the bone marrow protection and efficacy and safety of Trilaciclib in patients with locally advanced/metastatic TNBC who had previously received at least two chemotherapy regimes prior to treatment with Eribulin.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib Plus Eribulin | Experimental | Drug: Trilaciclib, Drug: EribulinTrilaciclib: 240mg/m², intravenous infusion for 30 minutes, and completed within 4 hours before chemotherapy administration on day 1 and day 8, day 21 was 1 cycle; Eribulin: 1.4mg/m², intravenous infusion at day 1 and day 8, with 1 cycle at day 21; Note: Trilaciclib combined with Eribulin was treated for cycles 1-2, and continued use of trilaciclib combined with eribulin was a clinical decision from cycle 3 onwards.The infusion interval between treacilil and subsequent injections should not exceed 4 hours. Hematopoietic growth factor, blood transfusion, or platelet transfusion are not allowed during the week prior to the blood test during the subject screening period, and no prophylaxis of any cytogenic subclass drugs (including granulocyte colony stimulating factor, granulocyte giant cell colony co-stimulating factor, and erythropoietin) is allowed during the first cycle.However, it can be used therapeutically and should be used in strict accordance with relevant guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years old , no limitation of gender;
- locally advanced or metastatic triple-negative breast cancer;
- have received at least two prior chemotherapy regimens(The recurrence of the last adjuvant chemotherapy is counted one line within 12 months after surgery);
- At least one measurable lesion according to RECIST version 1.1;
- The laboratory tests meet the following criteria:
Key exclusion criteria (10 listed)
- Diagnosed other malignant disease besides breast cancerwithin 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection);
- Main organ function not good enough;
- Bone marrow invasion;
- Require combined chemotherapy other than Eribulin;
- Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment;
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 |
|---|---|---|
| TrilaciclibEach participant receives Trilaciclib(240mg/m², intravenous infusion for 30 minutes, and completed within 4 hours before chemotherapy administration on day 1 and day 8, day 21 was 1 cycle) | Drug | Trilaciclib Plus Eribulin |
| EribulinEach participant receives Eribulin(1.4mg/m², intravenous infusion at day 1 and day 8, with 1 cycle at day 21) | Drug | Trilaciclib Plus Eribulin |
Primary outcome
Prevalence of grade 3 neutropenia during cycle 1-2 of chemotherapy treatment
Time frame: 6 months
evaluated by CIM related index(Chemotherapy-Induced Myelosuppression) , CTCAE5.0(Common Terminology Criteria for Adverse Events)
7 secondary outcomes
Anti-tumor efficacy
Time frame: 6 months
Adverse events, abnormal laboratory tests, etal
Time frame: 6 months
Bone marrow protection
Time frame: 6 months
Disease burden(cost)
Time frame: 6 months
Disease burden(in-stay time)
Time frame: 6 months
Disease burden(quality of life)
Time frame: 6 months
Compliance with the chemotherapy regimen
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
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 Trilaciclib and Eribulin in people with Breast Cancer, run by Sun Yat-sen University 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 1 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Xu, MD (13711277870, xufei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of grade 3 neutropenia during cycle 1-2 of chemotherapy treatment (time frame: 6 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 1 Dec 2025.