Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer

NCT07771881 | Not Yet Recruiting Phase 2

• 1 other identifier: 2606-Exp645
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Thrombocytopenia Chemotherapy Induced

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  until the end of each treatment cycle, an average of 3 weeks

• Minimum and maximum platelet counts

  through study completion, an average of 1year

• Number of symptomatic bleeding episodes during the treatment period

  through study completion, an average of 1year

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  through study completion, an average of 1year

Study Arms (1)

Romiplostim N01 for Injection

EXPERIMENTAL

Romiplostim N01 for Injection

Drug: Romiplostim N01

Interventions

Romiplostim N01 DRUG

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.

Romiplostim N01 for Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Central Study Contacts

Zhimin Shao

CONTACT

+86 64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Breast Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)