RecruitingPhase 2NCT05394285

A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer

A Multicenter, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer


Sponsor

Henan Cancer Hospital

Enrollment

60 participants

Start Date

Aug 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study now plans to explore the efficacy and safety of hetrombopag in cancer therapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing hetrombopag olamine — a drug that stimulates the bone marrow to produce more platelets (the blood cells responsible for clotting) — in people with advanced breast cancer who develop low platelet counts as a side effect of chemotherapy. Low platelet counts often force doctors to delay or reduce chemo doses, which may affect how well the cancer is treated. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced breast cancer confirmed by biopsy or pathology - Your platelet count has dropped significantly as a result of your chemotherapy - You are currently receiving or planning to receive chemotherapy **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are unable to understand the study or provide informed consent - Your doctor determines other circumstances make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHetrombopag

The first anti-tumor treatment cycle (multicenter, open label, randomized controlled): When platelets were \<50\*109/L, oral hetrombopag 7.5 mg/day was started. When the platelet count is \>100\*109/L, the administration is suspended. 2nd anti-tumor treatment cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after anti-tumor treatment for 14 days.


Locations(2)

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, China

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NCT05394285


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