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

NCT ID: NCT05394285

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-19
• Study Completion Date: 2025-08-01

Brief 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.

Detailed Description

Cancer therapy-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 cancer therapy-induced thrombocytopenia (CTIT). 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 CTIT patients is ongoing. 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 therapy-induced platelets.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hetrombopag Olamine tablets

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.

Group Type: EXPERIMENTAL

Hetrombopag

Intervention Type: DRUG

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.

rhTPO

The first anti-tumor treatment cycle (multicenter, 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 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.

Group Type: OTHER

Hetrombopag

Intervention Type: DRUG

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.

Interventions

Hetrombopag

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

min yan

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Henan Cancer Hospital

Zhengzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

min yan

Role: CONTACT

ym200678@126.com

15713857388

Facility Contacts

Min Yan, Professor

Role: primary

ym200678@126.com

+86 15713857388

Min Yan

Role: primary

ym200678@126.com

+86 15713857388

Other Identifiers

HNCH-MBC10

Identifier Type: -

Identifier Source: org_study_id