Triple Negative Breast CancerPhase 2NCT06955156
Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC
A Phase 2 study testing Trilaciclib in people with Triple Negative Breast Cancer, run by QIAO LI at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Trilaciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2023to 1 Jul 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fully understand and voluntarily participate in this study and sign the informed consent form.
- Age ≥18 and ≤75 years.
- Newly diagnosed TNBC with stage T1c N1-3 or stage T2-4 N0-3.
- Patients scheduled to receive neoadjuvant therapy.
- Patients have measurable lesions (non-lymph node lesions ≥10 mm in length and lymph node lesions ≥15 mm in length according to RECIST 1.1 standards).
- No previous antitumor system therapy.
Show all 9Show fewer
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
- Patients voluntarily joined the study with nice compliance.
- Good organ function (no blood transfusion or growth factor support within 2 weeks before the first dose of trial medication): WBC≥3.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥75×10^9/L, Hb≥90g/L, ALP≤5×ULN, ALT≤3×ULN, AST≤3×ULN, ALB≥28 g/L, Creatinine≤1.5×ULN or Creatinine clearance ≥50 mL/min, INR≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN (If patient is receiving anticoagulant therapy, as long as the PT INR is within the prescribed range of anticoagulants).
Who cannot join
- Pathological diagnosis of HR+ or HER2+ breast cancer.
- Imaging shows metastatic breast cancer.
- Previous or current concurrent malignancy other than breast cancer.
- Patients had any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary vasculitis, nephritis, hyperthyroidism; Patients had vitiligo; Patients who had complete remission of asthma in childhood and without any intervention in adulthood were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
- Patients are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose > 10mg/day of prednisone or other therapeutic hormone) and continued use within 2 weeks prior to enrollment.
- Recurrence after surgery, previous local or systemic antitumor therapy.
Show all 12Show fewer
- Patients are known to have a prior allergy to the drug ingredient being applied.
- Patients with poorly controlled cardiac clinical symptoms or diseases, such as (1)NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Patients with active infection or unexplained fever during screening or prior to initial treatment >38.5℃ (as determined by the investigator, the subject's fever due to the tumor can be enrolled).
- Live vaccine was administered less than 4 weeks before or possibly during the study period
- Patients have a known history of psychotropic substance abuse, alcohol abuse, or druggy use.
- Patients should be excluded if, in the investigator's judgment, the subjects have other factors that may cause the study to be terminated (other severe medical conditions requiring concomitant treatment, serious laboratory abnormalities, associated family or social factors, and other circumstances that may affect the safety of the subjects or the collection of data and samples).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, 100021
Binghe Xu, Dr., 86-10-87788495, xubinghe@medmail.com.cn
About this study
Official title: Trilaciclib in Combination With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced Triple-negative Breast Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Study
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. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.
Read the detailed description
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 so on. In addition, myelosuppression usually leads to a lower dose or more extended 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. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Trilaciclib
- 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.
TrilaciclibDrug
Also called Cosela
trilaciclib 240mg/m2 ivgtt d1 Q3w; anti-PD-1 antibody 200mg ivgtt d1 Q3w; Paclitaxel-albumin 250mg/m2 ivgtt d1 Q3w or 125mg/m2 ivgtt d1,d8 Q3w; carboplatin AUC=5 ivgtt d1 Q3w; Review every 2 cycles until the best efficacy or intolerable toxicity, usually 6-8 cycles;
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Trilaciclib + Anti-PD-1 Antibody + Chemotherapy Receives: Drug: Trilaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ≥ grade 3 neutropenia during chemotherapy
Incidence of ≥ grade 3 neutropenia during chemotherapy. (neutrophil count ≤ 1*10^9/L）
Measured: At the end of Cycle 1 (each cycle is 21days)
Secondary outcomes (8)
event-free survival
Time from randomization to occurrence of any event
Measured: one year after the last dose
Duration of grade 3 or 4 neutropenia in the first treatment cycle of chemotherapy (days);
Duration of grade 3 or 4 neutropenia in the first treatment cycle of chemotherapy (days)
Measured: From the initiation of the first dose to 28 days after the last dose
The incidence of grade 3 or 4 thrombocytopenia
The incidence of grade 3 or 4 thrombocytopenia (Platelet<50×109/L)
Measured: From the initiation of the first dose to 28 days after the last dose
The incidence of grade 3 or 4 anemia during chemotherapy treatment
The incidence of grade 3 or 4 anemia during chemotherapy treatment (HGB<80g/L)
Measured: From the initiation of the first dose to 28 days after the last dose
Incidence of adverse events (AES) and serious adverse events (SAEs)
The incidence of adverse events (AES) and serious adverse events (SAEs), and the incidence of AES/SAEs leading to treatment termination
Measured: From the initiation of the first dose to 28 days after the last dose
pathologic complete response (pCR)
Proportion of patients with no residual invasive tumor cells on pathological examination of primary breast lesions and axillary lymph node surgical specimens of all patients
Measured: At the end of Cycle 6-8 (each cycle is 21 days)
Utilization rate of Granulocyte colony stimulation (G-CSF)
Utilization rate of Granulocyte colony stimulation (G-CSF)
Measured: From the initiation of the first dose to 28 days after the last dose
All-cause chemotherapy dose reduction rate.
All-cause chemotherapy dose reduction rate.
Measured: From the initiation of the first dose to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start3 Jul 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QIAO LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, QIAO LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Qiao Li, Principal investigator, National Cancer Center/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955156
- Sponsor's protocol ID
- Trila-CN-BC-01
- Status last verified
- Jul 2024
- First submitted
- 3 Aug 2024
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trilaciclib in Combination With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced Triple-negative Breast Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06955156
- Acronym / sponsor ID
- Trila-CN-BC-01
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- QIAO LIUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 2 May 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.
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. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.
Detailed description
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 so on. In addition, myelosuppression usually leads to a lower dose or more extended 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. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: TrilaciclibTrilaciclib + Anti-PD-1 Antibody + Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients fully understand and voluntarily participate in this study and sign the informed consent form.
- Age ≥18 and ≤75 years.
- Newly diagnosed TNBC with stage T1c N1-3 or stage T2-4 N0-3.
- Patients scheduled to receive neoadjuvant therapy.
- Patients have measurable lesions (non-lymph node lesions ≥10 mm in length and lymph node lesions ≥15 mm in length according to RECIST 1.1 standards).
Key exclusion criteria (12 listed)
- Pathological diagnosis of HR+ or HER2+ breast cancer.
- Imaging shows metastatic breast cancer.
- Previous or current concurrent malignancy other than breast cancer.
- Patients had any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary vasculitis, nephritis, hyperthyroidism; Patients had vitiligo; Patients who had complete remission of asthma in childhood and without any intervention in adulthood were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
- Patients are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose > 10mg/day of prednisone or other therapeutic hormone) and continued use within 2 weeks prior to 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 |
|---|---|---|
| TrilaciclibAlso: Coselatrilaciclib 240mg/m2 ivgtt d1 Q3w; anti-PD-1 antibody 200mg ivgtt d1 Q3w; Paclitaxel-albumin 250mg/m2 ivgtt d1 Q3w or 125mg/m2 ivgtt d1,d8 Q3w; carboplatin AUC=5 ivgtt d1 Q3w; Review every 2 cycles until the best efficacy or intolerable toxicity, usually 6-8 cycles; | Drug | Experimental |
Primary outcome
Incidence of ≥ grade 3 neutropenia during chemotherapy
Time frame: At the end of Cycle 1 (each cycle is 21days)
Incidence of ≥ grade 3 neutropenia during chemotherapy. (neutrophil count ≤ 1*10^9/L）
8 secondary outcomes
event-free survival
Time frame: one year after the last dose
Duration of grade 3 or 4 neutropenia in the first treatment cycle of chemotherapy (days);
Time frame: From the initiation of the first dose to 28 days after the last dose
The incidence of grade 3 or 4 thrombocytopenia
Time frame: From the initiation of the first dose to 28 days after the last dose
The incidence of grade 3 or 4 anemia during chemotherapy treatment
Time frame: From the initiation of the first dose to 28 days after the last dose
Incidence of adverse events (AES) and serious adverse events (SAEs)
Time frame: From the initiation of the first dose to 28 days after the last dose
pathologic complete response (pCR)
Time frame: At the end of Cycle 6-8 (each cycle is 21 days)
Utilization rate of Granulocyte colony stimulation (G-CSF)
Time frame: From the initiation of the first dose to 28 days after the last dose
All-cause chemotherapy dose reduction rate.
Time frame: From the initiation of the first dose to 28 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
Related trials for Triple Negative Breast Cancer
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 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
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.
Qiao Li principal investigator
National Cancer Center/Cancer Hospital
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 in people with Triple Negative Breast Cancer, run by QIAO LI 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 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu (86-10-87788495, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ≥ grade 3 neutropenia during chemotherapy (time frame: At the end of Cycle 1 (each cycle is 21days)). 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 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.