Herombopag Treated T-DM1 Induced Platelet Reduction
About this study
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.
- Condition
- Thrombocytopenia
- Tested
- Herombopag Olamine Tablets
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 22
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Thrombocytopenia
- Inclusion:
- 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;
- Planned to undergo at least two additional treatment cycles including T-DM1 administration, with the dose of T-DM1 in the current cycle consistent with the previous cycle;
- Expected survival of ≥12 weeks and able to tolerate the current treatment regimen for at least two cycles or more;
- Expected to have good compliance, able to follow up on treatment efficacy and adverse reactions as required by the protocol.
- Exclusion:
- A history of other malignant tumors diagnosed within the past 3 years;
- Patients with mental or neurological disorders who are unable to cooperate;
- Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplantation;
- Patients with hematopoietic system disorders other than chemotherapy-induced thrombocytopenia (CTIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome;
- Patients with a history of any arterial or venous thrombotic events within the past 6 months prior to screening;
- Severe bleeding manifestations within 2 weeks prior to screening, such as gastrointestinal or central nervous system bleeding;
- Participation in a clinical trial of the same type of drug within 4 weeks prior to enrollment;
- Pregnant or lactating women;
- Patients with a history of hypersensitivity to the study drug;
- Patients deemed ineligible by the investigator.
Where
1 site, 1 recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Contact
-
Tao Qin, MD
86-02034071337 qintao5471@163.com
Potential match only. Final eligibility is determined by the study team.