Romiplostim N01 / Thrombocytopenia Chemotherapy Induced · Phase 2 Trial

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

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration evaluating romiplostim N01 for secondary prophylaxis of chemotherapy-induced thrombocytopenia in breast cancer patients. No results have been posted to the registry; the study has not yet begun recruitment and is therefore at the planning stage only.

What was studied

Phase 2, Interventional, Single Group, Open label, Supportive Care purpose. Thrombocytopenia Chemotherapy Induced; age from 18 Years; to 75 Years. Intervention: Romiplostim N01 for Injection. n = 53. 1 site: China.

Key findings

Safety

Efficacy and safety outcomes are not yet available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 trial registration with no reported results; the study is not yet recruiting and contains only planned design and endpoints.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Proportion of patients achieving response (assessed at up to the completion of two consecutive treatment cycles, an average of 6 weeks)

DesignPhase 2, Interventional, Single Group, Open label, Supportive Care purpose

PopulationThrombocytopenia Chemotherapy Induced; age from 18 Years; to 75 Years

Sample size53

InterventionRomiplostim N01 for Injection

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment53

PhasePhase 2

Primary outcome measureProportion of patients achieving response, up to completion of two consecutive treatment cycles, an average of 6 weeks

Caveats

This is a registry record only; no results are reported and recruitment has not begun.
Efficacy and safety outcomes are not yet available.
No comparator arm is described in the registry entry.
Blinding, randomization, and detailed eligibility criteria are not specified in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design appropriate for early efficacy and safety evaluation.

Directness

strong

Studies the drug and population of interest directly; prophylaxis in CIT.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record lacks detail on blinding, allocation concealment, or conduct.

Sample adequacy

limited

Estimated 53 participants; modest size for Phase 2 efficacy claim.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07771881). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 53 participants (ESTIMATED). Conditions: Thrombocytopenia Chemotherapy Induced. Interventions: DRUG: Romiplostim N01. Primary outcome measures: Proportion of patients achieving response , up to the completion of two consecutive treatment cycles, an average of 6 weeks. 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Romiplostim N01Fudan UniversityThrombocytopenia Chemotherapy InducedNCT07771881