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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Herombopag, initial dose 7.5 mg po qd d1-14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herombopag Olamine Tablets | Drug | Herombopag 7.5 mg po qd,d1-14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of grade I thrombocytopenia according to CTCAE4.0 | The proportion of patients with platelet counts <100 × 109/L according to CTCAE4.0 | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of salvage platelet transfusion therapy | Proportion of patients requiring platelet transfusion therapy during treatment | From enrollment to the end of treatment at 6 weeks |
| time to platelet counts ≥100 × 109/L |
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Inclusion:
Exclusion:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Qin, MD | Contact | 86-02034071337 | qintao5471@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yinduo Zeng, MD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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Median time to achieve and maintain platelet counts ≥100 × 109/L from the start of Hetrombopag until the next treatment cycle;
| From enrollment to the end of treatment at 6 weeks |
| Proportion of T-DM1with unexpected administration | Proportion of patients who experienced delay, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia | From enrollment to the end of treatment at 6 weeks |
| proportion of adverse events | According to CTC AE 4.0 to evaluate profile of adverse events | From enrollment to the end of treatment at 6 weeks |