Cytotoxic DrugsNCT07162519
Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients
A study testing romiplostim N01 in people with Cytotoxic Drugs and Romiplostim N01, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The primary study objective: To evaluate the efficacy of romiplostim (N01) in the treatment of chemotherapy-induced thrombocytopenia (CIT) in breast cancer patients by assessing the proportion of patients whose platelet count recovers to ≥100×10⁹/L after two weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cytotoxic Drugs, Romiplostim N01, Breast Cancer
- What is being tested?
- romiplostim N01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 30 Nov 2026
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form must be obtained prior to enrollment;
- Aged 18-75 years;
- Patients with histologically or pathologically confirmed breast cancer;
- Breast cancer patients with chemotherapy-induced thrombocytopenia (CTIT);
- No prior treatment with romiplostim or romiplostim N01 within 3 months;
- ECOG PS score: 0-2;
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- Platelet count <75×10⁹/L;
- Expected survival period ≥12 weeks at screening;
- Subjects of childbearing potential must agree to use reliable contraception throughout the study period (including male or female condoms, contraceptive foam, gel, film, cream, suppositories, abstinence, or intrauterine devices, etc.). Exceptions include female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or postmenopausal status for over 1 year, and male subjects who have undergone bilateral vasectomy or ligation;
- Voluntarily participate in the study, sign informed consent, and demonstrate good compliance.
Who cannot join
- Presence of hematopoietic system diseases other than chemotherapy-induced thrombocytopenia (CIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes;
- Platelet reduction due to causes other than CIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infection, or hemorrhage;
- Bone marrow infiltration or bone marrow metastasis;
- Prior radiotherapy to the pelvis, spine, or large-field bone irradiation within 3 months before screening, or current/scheduled radiotherapy;
- History of severe cardiovascular diseases within 6 months prior to screening, such as congestive heart failure (NYHA Class III-IV), arrhythmias known to increase thromboembolic risk (e.g., atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting;
- Clinical manifestations of severe hemorrhage within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;
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- Brain tumors or brain metastases;
- Conditions requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression;
- Absolute neutrophil count <1.0×10⁹/L or hemoglobin <80 g/L (use of granulocyte colony-stimulating factor, red blood cell transfusions, or EPO therapy per clinical practice is allowed);
- Significant liver dysfunction: For patients without liver metastases, ALT/AST >3×ULN (upper limit of normal) or TBIL >3×ULN; for patients with liver metastases, ALT/AST ≥5×ULN or TBIL ≥5×ULN;
- Renal dysfunction: Serum creatinine ≥1.5×ULN or eGFR ≤60 mL/min (calculated by Cockcroft-Gault formula);
- Known or expected hypersensitivity or intolerance to romiplostim N01 or excipients of rhTPO; 13．HIV-infected patients; 14．Pregnant or lactating women; 15．Participation in any other clinical trial involving investigational drugs or devices within 3 months prior to screening; 16．Other situations deemed by the investigator to pose significant risks to the subject's health or safety, or potentially affecting efficacy evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-arm, Multicenter Clinical Study of Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients.
The primary study objective:
To evaluate the efficacy of romiplostim (N01) in the treatment of chemotherapy-induced thrombocytopenia (CIT) in breast cancer patients by assessing the proportion of patients whose platelet count recovers to ≥100×10⁹/L after two weeks of treatment.
Read more
This study is a multicenter, single-arm, interventional trial. It plans to enroll 68 breast cancer patients with chemotherapy-induced thrombocytopenia (CIT) (PLT <75×10⁹/L).
The study comprises a Screening Period (from after the subject signs the informed consent form until before the first dose), a Treatment Period (including treatment with romiplostim N01), and a Follow-up Period.
Screening Period: Subjects will be evaluated against the inclusion and exclusion criteria. Those who qualify may proceed to the Treatment Period.
Treatment Period: Eligible subjects from screening will undergo a baseline visit and will receive romiplostim N01 once weekly for a maximum of 4 weeks. Dosing will be stopped when the platelet count increases to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) will be performed for subjects with a baseline platelet level of <50×10⁹/L before the administration of the anti-tumor therapy drugs.
Dosage Regimen:
Romiplostim N01: 200 μg per dose, administered subcutaneously, once weekly.
Follow-up Period: Subjects will enter the Follow-up Period after the completion of the treatment.
- Conditions
- Cytotoxic Drugs, Romiplostim N01, Breast Cancer
- Being tested
- romiplostim N01
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
romiplostim N01Drug
Eligible subjects who pass the screening will undergo a baseline visit and will receive romiplostim N01 administration once weekly for a maximum of 4 weeks. Dosing will be discontinued when the platelet count rises to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, those with a baseline platelet count of <50×10⁹/L will receive prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) before the anti-tumor drugs are given.
| Study group | Role | What they receive |
|---|---|---|
| Drug Intervention Group - Treated with Romiplostim N01 | Experimental | Not described Receives: Drug: romiplostim N01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week response rate
The proportion of patients whose platelet count recovers to ≥100×10⁹/L within 2 weeks of treatment.
Measured: 2 weeks
Secondary outcomes (10)
The median time for platelet count to recover to ≥75×10⁹/L after treatment;
The median time for platelet count to recover to ≥75×10⁹/L after treatment;
Measured: 1 month
The proportion of patients achieving a platelet count recovery to ≥75×10⁹/L within 2 weeks of treatment.
The proportion of patients achieving a platelet count recovery to ≥75×10⁹/L within 2 weeks of treatment.
Measured: 2 weeks
The absolute value of the change in platelet count from baseline within 2 weeks of treatment.
The absolute value of the change in platelet count from baseline within 2 weeks of treatment.
Measured: 1 month
The proportion of patients achieving an increase in platelet count of ≥30×10⁹/L from baseline within 2 weeks of treatment.
The proportion of patients achieving an increase in platelet count of ≥30×10⁹/L from baseline within 2 weeks of treatment.
Measured: 2 weeks
The median time to platelet count recovery to ≥100×10⁹/L following treatment initiation.
The median time to platelet count recovery to ≥100×10⁹/L following treatment initiation.
Measured: 1 month
The proportion of patients who resumed antitumor therapy within two weeks.
The proportion of patients who resumed antitumor therapy within two weeks.
Measured: 2 weeks
The maximum platelet count within two weeks of treatment.
The maximum platelet count within two weeks of treatment.
Measured: 2 weeks
The number of platelet transfusions and the transfusion volume during the study period.
The number of platelet transfusions and the transfusion volume during the study period.
Measured: 1 month
The proportion of patients with a dose reduction of cytotoxic drugs by ≥15% due to CTIT following secondary prophylaxis.
The proportion of patients with a dose reduction of cytotoxic drugs by ≥15% due to CTIT following secondary prophylaxis.
Measured: 1 month
The proportion of patients who developed CTIT after secondary prophylaxis.
The proportion of patients who developed CTIT after secondary prophylaxis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytotoxic DrugsStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Cancer Hospital and Institute, Tangshan People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162519
- Sponsor's protocol ID
- QL-CTIT-RULS-1002
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Clinical Study of Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT07162519
- Acronym / sponsor ID
- QL-CTIT-RULS-1002
- Conditions
- Cytotoxic Drugs, Romiplostim N01, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Cancer Hospital and Institute, Tangshan People's Hospital
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Sep 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.
The primary study objective:
To evaluate the efficacy of romiplostim (N01) in the treatment of chemotherapy-induced thrombocytopenia (CIT) in breast cancer patients by assessing the proportion of patients whose platelet count recovers to ≥100×10⁹/L after two weeks of treatment.
This study is a multicenter, single-arm, interventional trial. It plans to enroll 68 breast cancer patients with chemotherapy-induced thrombocytopenia (CIT) (PLT <75×10⁹/L).
The study comprises a Screening Period (from after the subject signs the informed consent form until before the first dose), a Treatment Period (including treatment with romiplostim N01), and a Follow-up Period.
Screening Period: Subjects will be evaluated against the inclusion and exclusion criteria. Those who qualify may proceed to the Treatment Period.
Treatment Period: Eligible subjects from screening will undergo a baseline visit and will receive romiplostim N01 once weekly for a maximum of 4 weeks. Dosing will be stopped when the platelet count increases to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) will be performed for subjects with a baseline platelet level of <50×10⁹/L before the administration of the anti-tumor therapy drugs.
Dosage Regimen:
Romiplostim N01: 200 μg per dose, administered subcutaneously, once weekly.
Follow-up Period: Subjects will enter the Follow-up Period after the completion of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Intervention Group - Treated with Romiplostim N01 | Experimental | Drug: romiplostim N01 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form must be obtained prior to enrollment;
- Aged 18-75 years;
- Patients with histologically or pathologically confirmed breast cancer;
- Breast cancer patients with chemotherapy-induced thrombocytopenia (CTIT);
- No prior treatment with romiplostim or romiplostim N01 within 3 months;
Key exclusion criteria (12 listed)
- Presence of hematopoietic system diseases other than chemotherapy-induced thrombocytopenia (CIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes;
- Platelet reduction due to causes other than CIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infection, or hemorrhage;
- Bone marrow infiltration or bone marrow metastasis;
- Prior radiotherapy to the pelvis, spine, or large-field bone irradiation within 3 months before screening, or current/scheduled radiotherapy;
- History of severe cardiovascular diseases within 6 months prior to screening, such as congestive heart failure (NYHA Class III-IV), arrhythmias known to increase thromboembolic risk (e.g., atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting;
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 |
|---|---|---|
| romiplostim N01Eligible subjects who pass the screening will undergo a baseline visit and will receive romiplostim N01 administration once weekly for a maximum of 4 weeks. Dosing will be discontinued when the platelet count rises to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, those with a baseline platelet count of <50×10⁹/L will receive prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) before the anti-tumor drugs are given. | Drug | Drug Intervention Group - Treated with Romiplostim N01 |
Primary outcome
2-week response rate
Time frame: 2 weeks
The proportion of patients whose platelet count recovers to ≥100×10⁹/L within 2 weeks of treatment.
10 secondary outcomes
The median time for platelet count to recover to ≥75×10⁹/L after treatment;
Time frame: 1 month
The proportion of patients achieving a platelet count recovery to ≥75×10⁹/L within 2 weeks of treatment.
Time frame: 2 weeks
The absolute value of the change in platelet count from baseline within 2 weeks of treatment.
Time frame: 1 month
The proportion of patients achieving an increase in platelet count of ≥30×10⁹/L from baseline within 2 weeks of treatment.
Time frame: 2 weeks
The median time to platelet count recovery to ≥100×10⁹/L following treatment initiation.
Time frame: 1 month
The proportion of patients who resumed antitumor therapy within two weeks.
Time frame: 2 weeks
The maximum platelet count within two weeks of treatment.
Time frame: 2 weeks
The number of platelet transfusions and the transfusion volume during the study period.
Time frame: 1 month
The proportion of patients with a dose reduction of cytotoxic drugs by ≥15% due to CTIT following secondary prophylaxis.
Time frame: 1 month
The proportion of patients who developed CTIT after secondary prophylaxis.
Time frame: 1 month
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 9 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing romiplostim N01 in people with Cytotoxic Drugs and Romiplostim N01, run by Tianjin Medical University Cancer Institute and Hospital.
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 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Yehui Shi (+8618622221183, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-week response rate (time frame: 2 weeks). 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 9 Sep 2025.