Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Romiplostim N01
Treatment groups
53 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov