Breast cancer
Conditions
Interventions
Experimental group:Preventive administration of ?Herombopag Olamine tablets?
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years, regardless of gender. 2.Patients with pathologically or cytologically confirmed HER2-positive breast cancer who, after neoadjuvant therapy with non-pathological complete response (non-pCR), are scheduled to receive T-DM1 adjuvant intensive therapy. 3.Patients who previously received neoadjuvant chemoradiotherapy, with an interval of more than 1 month since the last anti-tumor treatment, and the upcoming targeted therapy is the first cycle of this treatment phase. 4.Expected survival time of >=14 weeks. 5.ECOG performance status (PS) score of 0–1. 6.Laboratory values meeting the following criteria: (1) Renal function: Serum creatinine (Cr) = 55 ml/min. (2) Liver function: Total bilirubin 38°C. 11.Good expected compliance and ability to follow the protocol for efficacy and adverse event follow-up.
Exclusion criteria
Exclusion criteria: 1.Platelet count (PLT) 300 × 10^9/L before primary prophylaxis. 3.History of thrombocytopenia caused by non-cancer-related treatments within 6 months prior to screening, including but not limited to cirrhosis, hypersplenism, infections, or bleeding. 4.Concurrent hematologic diseases or hematologic malignancies. 5.Currently taking non-chemotherapy medications known to cause thrombocytopenia, such as rifampicin or sulfonamides. 6.History of hematopoietic stem cell transplantation or organ transplantation. 7.Presence of thromboembolic diseases. 8.Bone marrow infiltration or bone marrow metastasis. 9.Received pelvic, spinal, or extended-field bone radiotherapy within 3 months prior to screening. 10.Concurrent participation in other clinical trials or use of other investigational drugs. 11.Pregnant or breastfeeding women. 12.Received anticoagulant or antithrombotic therapy (excluding heparin sodium for catheter flushing) within 7 days prior to screening, including heparin, warfarin, or non-steroidal anti-inflammatory drugs (NSAIDs). 13.Received glucocorticoid treatment within 1 month prior to screening (excluding use for chemotherapy premedication, anti-allergy, or antiemesis purposes, and dosage not exceeding 1 mg/kg/day of prednisone or equivalent, e.g., =60 mg/day for a 60 kg adult). 14.Received thrombopoietin receptor agonists (e.g., eltrombopag, romiplostim), recombinant human thrombopoietin (rhTPO), or recombinant human interleukin-11 (rhIL-11) within 1 month prior to screening. 15.Considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall incidence of Chemotherapy-induced thrombocytopenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade III.~IV CTIT;Proportion of TDM1 treatment discontinuance due to thrombocytopenia;Number and volume of platelet transfusions;Duration of grade 3 and above thrombocytopenia;Lowest platelet count;Time for platelets to recover from nadir to >=100×10^9/L; | — |
Countries
China
Contacts
Public ContactYu Yang
Zhejiang Cancer Hospital
Outcome results
None listed