A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Single-center, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394285
• Other study ID #: HNCH-MBC10
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2022
• Est. completion date: December 28, 2024

Study information

• Verified date: September 2023
• Source: Henan Cancer Hospital
• Contact: min yan
• Phone: 15713857388
• Email: ym200678[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Chemotherapy-induced thrombocytopenia increases the risk of hemorrhagic complications, the need for platelet transfusions, and limits the dose of cytotoxic drugs in the treatment of certain malignancies. Thrombopoietin receptor agonist (TPO-RA) has a therapeutic effect on chemotherapy-induced thrombocytopenia (CIT). As an innovative TPO-RA drug, hetrombopag has a more optimized molecular structure and reduced liver and kidney toxicity. A registrational Phase III clinical study in CIT patients is ongoing. This study now plans to explore the efficacy and safety of hetrombopag in chemotherapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The patients signed the informed consent and voluntarily joined the study;

2. Age 18-75 years old, male or female;

3. Patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen;

4. Can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles;

5. The first occurrence of platelets <50×109/L in the current chemotherapy cycle;

6. The investigator determines that the patient can receive hetrombopag administration;

7. Neutrophil count = 1.0×109/L, hemoglobin = 80g/L before administration of Haitrombopag;

8. Life expectancy at screening = 12 weeks;

9. ECOG: 0-1;

10. The main organ functions are normal, and there are no serious complications.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding;

2. Unable to understand the research nature of the research or have not obtained informed consent;

3. The investigator judges other circumstances that are not suitable for inclusion in the study;

4. Thrombocytopenia caused by other causes (chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);

5. Patients with unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent history (within 1 year of screening) of myocardial infarction;

6. Those with a history of blood disease or tumor bone marrow infiltration;

7. Those who received simultaneous radiotherapy and those who received pelvic radiotherapy in the past;

8. Arterial or venous thrombotic events within the past 6 months;

9. There are currently uncontrollable infections;

10. Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;

11. Need emergency treatment, such as superior vena cava syndrome, spinal cord compression;

12. The absolute value of neutrophils is less than 1.0×109/L, and the hemoglobin is less than 80g/L, and granulocyte colony-stimulating factor, red blood cells, and EPO infusion therapy in accordance with clinical routine are allowed;

13. Obvious abnormal liver function: patients without liver metastases, ALT/AST>3ULN (upper limit of normal value), TBIL>3ULN; patients with liver metastases, ALT/AST=5ULN, TBIL=5ULN;

14. Abnormal renal function: serum creatinine = 1.5ULN or eGFR = 60 ml/min (Cockcroft-Gault formula);

16. Received thrombopoietin receptor agonist drugs (such as Eltrombopag, Romigrastim), or recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL) within 1 month before screening -11) Treatment; 17. Received platelet transfusion within 3 days before randomization; 18. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of Hetrombopag ethanolamine tablets.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Thrombocytopenia

Intervention

Drug:
• Hetrombopag
The first chemotherapy cycle (single center, 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 chemotherapy 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 chemotherapy for 14 days.
• rh-TPO
The first chemotherapy cycle (single center, open label, randomized controlled): Start using rh-TPO 15000 units/day (subcutaneous injection) when platelets are less than 50*109/L. When the platelet count is more than 100*109/L, the administration is suspended. 2nd chemotherapy 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 chemotherapy for 14 days.

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of response rates to platelet-raising therapy in two chemotherapy cycles	Definition of response: 1. No chemotherapy regimen adjustment due to thrombocytopenia (such as chemotherapy delay = 5 days, and/or chemotherapy dose reduction = 20%, chemotherapy discontinuation, etc.; 2. No platelet-raising rescue therapy; 3. No Grade 4 myelosuppression; 4. Grade 3 myelosuppression for a duration of = 1 week)	30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary	The lowest platelet value after chemotherapy;	The lowest platelet value after chemotherapy;	30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary	The incidence of platelets <50×109/L and <25×109/L;	The incidence of platelets <50×109/L and <25×109/L;	30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary	The duration of platelets <50×109/L and <25×109/L;	The duration of platelets <50×109/L and <25×109/L;	30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary	The time for platelets to recover to more than 100×109/L;	The time for platelets to recover to more than 100×109/L;	30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary	latelet recovery to the highest value after chemotherapy;	latelet recovery to the highest value after chemotherapy;	30day±3day after the last administration of Hetrombopag Olamine Tablets
Secondary	the incidence of adverse events;	the incidence of adverse events;	30day±3day after the last administration of Hetrombopag Olamine Tablets