Thrombocytopenia Chemotherapy InducedPhase 2NCT07771881
Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer
A Phase 2 study testing Romiplostim N01 in people with Thrombocytopenia Chemotherapy Induced, run by Fudan University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of Romiplostim N01 for Injection administered as secondary prophylaxis in breast cancer patients with chemotherapy-induced thrombocytopenia (CIT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thrombocytopenia Chemotherapy Induced
- What is being tested?
- Romiplostim N01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Apr 2030
- Phase
- Phase 2
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.
- Age 18 to 75 years, either sex.
- Histologically or pathologically confirmed breast cancer.
- Nadir platelet count <50×10⁹/L in the previous treatment cycle; OR nadir platelet count ≥50×10⁹/L but <75×10⁹/L in the previous chemotherapy cycle, plus at least one high-risk factor for bleeding as defined in the relevant guideline.
- Platelet count >100×10⁹/L at screening.
- No prior exposure to romiplostim/romiplostim N01.
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- Prior receipt of one or more antineoplastic therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, and immunotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy of ≥12 weeks.
Who cannot join
- Concomitant hematologic disorders;
- Prior radiation therapy to long bones or flat bones, or currently receiving/planned to receive radiation therapy (local radiation to the breast is permitted);
- Serious cardiac clinical symptoms or diseases within 6 months prior to screening;
- Thrombotic predisposition or currently receiving thrombolytic and/or anticoagulant therapy;
- Clinically significant bleeding symptoms within 2 weeks prior to screening, or definitive clinical manifestations of bleeding tendency;
- Complications requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression;
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- Significantly abnormal hepatic function: for patients without hepatic metastasis, ALT/AST >3×ULN and TBIL >3×ULN; for patients with hepatic metastasis, ALT/AST ≥5×ULN and TBIL ≥5×ULN;
- Renal function abnormality: serum creatinine ≥1.5×ULN or eGFR ≤60 mL/min (by Cockcroft-Gault formula);
- Receipt of romiplostim within 2 to 3 weeks prior to study drug administration;
- Known or suspected hypersensitivity or intolerance to romiplostim N01 or its excipients (including cellulose-lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate);
- HIV infection;
- Participation in any other clinical study of an investigational drug or device within 3 months prior to screening;
- Pregnant or lactating women;
- Any other condition that, in the investigator's opinion, may affect study results or lead to premature discontinuation of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai
Zhimin Shao, +86 64175590, zhimingshao@yahoo.com
About this study
Official title: A Prospective Clinical Study on the Efficacy and Safety of Romiplostim N01 for Injection for Secondary Prophylaxis in Breast Cancer Patients With Chemotherapy-Induced Thrombocytopenia (CIT)
This study aims to evaluate the efficacy and safety of Romiplostim N01 for Injection administered as secondary prophylaxis in breast cancer patients with chemotherapy-induced thrombocytopenia (CIT).
- Conditions
- Thrombocytopenia Chemotherapy Induced
- Being tested
- Romiplostim N01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romiplostim N01Drug
Romiplostim N01 for Injection: 3.0 µg/kg, QW. If the administration coincides with a chemotherapy day, the Romiplostim N01 for injection should be completed within 2 hours prior to chemotherapy. If no chemotherapy is scheduled on the planned dosing day, the injection timing is unrestricted. Thereafter, platelet counts should be monitored once or twice weekly.
Subsequent dose adjustments follow the principle of guideline-based titration: when platelet count is <50×10⁹/L, the dose is increased by 1-2 µg/kg per week; when platelet count is between 50×10⁹/L and 75×10⁹/L, the dose is increased by 1 µg/kg per week.
Treatment should be discontinued if Romiplostim N01 for injection at 10 µg/kg administered weekly for 4 consecutive weeks fails to achieve a response. Non-response is defined as a platelet count ≤75×10⁹/L after 4 weeks of continuous administration, accompanied by an increase from baseline of ≤30×10⁹/L over the same period.
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim N01 for Injection | Experimental | Romiplostim N01 for Injection Receives: Drug: Romiplostim N01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving response
Defined as platelet recovery over two consecutive cycles, with no dose modification (≥15% reduction, ≥4-day delay, or discontinuation) due to thrombocytopenia, and no rescue treatment.
Measured: up to the completion of two consecutive treatment cycles, an average of 6 weeks
Secondary outcomes (4)
Proportion of patients with platelet count <50×10⁹/L per cycle
Proportion of patients with platelet count <50×10⁹/L per cycle
Measured: until the end of each treatment cycle, an average of 3 weeks
Minimum and maximum platelet counts
To evaluate the minimum and maximum platelet counts throughout the entire treatment period.
Measured: through study completion, an average of 1year
Number of symptomatic bleeding episodes during the treatment period
Number of symptomatic bleeding episodes during the treatment period
Measured: through study completion, an average of 1year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion, an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia Chemotherapy InducedStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771881
- Sponsor's protocol ID
- 2606-Exp645
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No