Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients

What Was Tested

The trial (not phased) is built around Romiplostim.

This study is a multicenter, single-arm, interventional trial.

It had 1 arm (groups): Drug Intervention Group - Treated with Romiplostim N01 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 68 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent form must be obtained prior to enrollment;. Aged 18-75 years;. No prior treatment with romiplostim or romiplostim N01 within 3 months;. ECOG PS score: 0-2;. Platelet count \<75×10⁹/L;.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: 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;; clinical manifestations of severe hemorrhage within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-09-20 with completion listed for 2026-08-30.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 2-week response rate (time frame: 2 weeks).

It also tracked 10 secondary outcomes, for example The median time for platelet count to recover to ≥75×10⁹/L after treatment;, The proportion of patients achieving a platelet count recovery to ≥75×10⁹/L within 2 weeks of treatment, The absolute value of the change in platelet count from baseline within 2 weeks of treatment, The median time to platelet count recovery to ≥100×10⁹/L following treatment initiation, The proportion of patients who resumed antitumor therapy within two weeks and The maximum platelet count within two weeks of treatment.

What This Means in Plain Language

Put simply, this is a not phased trial of Romiplostim in 68 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.