Herombopag Treated T-DM1 Induced Platelet Reduction
ConditionThrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, any gender;
Pathologically diagnosed with breast cancer based on histological or cytological examination, and previously treated with neoadjuvant anti-HER-2 therapy followed by T-DM1 adjuvant therapy;
Experienced grade 2 or higher tumor treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to ≥100 × 109/L and ≤200 × 109/L prior to the next treatment;
ECOG performance status score: 0-2;
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Herombopag Olamine Tablets
DrugHerombopag 7.5 mg po qd，d1-14
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Treatment group AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of grade I thrombocytopenia according to CTCAE4.0
The proportion of patients with platelet counts \<100 × 109/L according to CTCAE4.0
Time frame
From enrollment to the end of treatment at 6 weeksSecondary outcomes
1
the proportion of salvage platelet transfusion therapy
Proportion of patients requiring platelet transfusion therapy during treatment
Time frame
From enrollment to the end of treatment at 6 weeks2
time to platelet counts ≥100 × 109/L
Median time to achieve and maintain platelet counts ≥100 × 109/L from the start of Hetrombopag until the next treatment cycle;
Time frame
From enrollment to the end of treatment at 6 weeks3
Proportion of T-DM1with unexpected administration
Proportion of patients who experienced delay, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia
Time frame
From enrollment to the end of treatment at 6 weeks4
proportion of adverse events
According to CTC AE 4.0 to evaluate profile of adverse events
Time frame
From enrollment to the end of treatment at 6 weeksSponsors and contacts
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Source ClinicalTrials.gov