Thrombocytopenia Chemotherapy Induced
Conditions
Brief 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).
Interventions
DRUGRomiplostim N01
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.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent form. 2. Age 18 to 75 years, either sex. 3. Histologically or pathologically confirmed breast cancer. 4. 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. 5. Platelet count \>100×10⁹/L at screening. 6. No prior exposure to romiplostim/romiplostim N01. 7. Prior receipt of one or more antineoplastic therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, and immunotherapy. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9. Life expectancy of ≥12 weeks.
Exclusion criteria
1. Concomitant hematologic disorders; 2. Prior radiation therapy to long bones or flat bones, or currently receiving/planned to receive radiation therapy (local radiation to the breast is permitted); 3. Serious cardiac clinical symptoms or diseases within 6 months prior to screening; 4. Thrombotic predisposition or currently receiving thrombolytic and/or anticoagulant therapy; 5. Clinically significant bleeding symptoms within 2 weeks prior to screening, or definitive clinical manifestations of bleeding tendency; 6. Complications requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression; 7. 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; 8. Renal function abnormality: serum creatinine ≥1.5×ULN or eGFR ≤60 mL/min (by Cockcroft-Gault formula); 9. Receipt of romiplostim within 2 to 3 weeks prior to study drug administration; 10. Known or suspected hypersensitivity or intolerance to romiplostim N01 or its excipients (including cellulose-lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate); 11. HIV infection; 12. Participation in any other clinical study of an investigational drug or device within 3 months prior to screening; 13. Pregnant or lactating women; 14. Any other condition that, in the investigator's opinion, may affect study results or lead to premature discontinuation of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving response | up to the completion of two consecutive treatment cycles, an average of 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with platelet count <50×10⁹/L per cycle | until the end of each treatment cycle, an average of 3 weeks | Proportion of patients with platelet count \<50×10⁹/L per cycle |
| Minimum and maximum platelet counts | through study completion, an average of 1year | To evaluate the minimum and maximum platelet counts throughout the entire treatment period. |
| Number of symptomatic bleeding episodes during the treatment period | through study completion, an average of 1year | Number of symptomatic bleeding episodes during the treatment period |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | through study completion, an average of 1year | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Countries
China
Contacts
CONTACTZhimin Shao
Outcome results
None listed