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

NCT05394285 | Recruiting Phase 2

• 1 other identifier: HNCH-MBC10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The response rates to platelet-raising therapy in prevention stage

  The response rate defined as the proportion of pts not requiring platelet transfusion or adjustment (dose reduction 20%, treatment delays for ≥5 days, or treatment discontinuation) due to thrombocytopenia, and not developing severe thrombocytopenia (PLT \< 25×10⁹/L, or PLT \<50×10⁹/L for \>7 days).

  30day±3day after the last administration of Hetrombopag Olamine Tablets

Secondary Outcomes (7)

• The response rate to platelet-raising therapy in treatment stage;

  30day±3day after the last administration of Hetrombopag Olamine Tablets or rh TPO

• The lowest platelet value after anti-tumor treatment;

  30day±3day after the last administration of Hetrombopag Olamine Tablets

• The incidence of platelets <50×109/L and <25×109/L;

  30day±3day after the last administration of Hetrombopag Olamine Tablets

• The duration of platelets <50×109/L and <25×109/L;

  30day±3day after the last administration of Hetrombopag Olamine Tablets

• The time for platelets to recover to more than 100×109/L;

  30day±3day after the last administration of Hetrombopag Olamine Tablets

Study Arms (2)

hetrombopag Olamine tablets

EXPERIMENTAL

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.

Drug: Hetrombopag

rhTPO

OTHER

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.

Drug: Hetrombopag

Interventions

Hetrombopag 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.

hetrombopag Olamine tablets; rhTPO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients signed the informed consent and voluntarily joined the study;
• Age 18-75 years old, male or female;
• Patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen;
• Can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles;
• The first occurrence of platelets \<50×109/L in the current chemotherapy cycle;
• The investigator determines that the patient can receive hetrombopag administration;
• Neutrophil count ≥ 1.0×109/L, hemoglobin ≥ 80g/L before administration of Haitrombopag;
• Life expectancy at screening ≥ 12 weeks;
• ECOG: 0-1;
• The main organ functions are normal, and there are no serious complications.

You may not qualify if:

• Women who are pregnant or breastfeeding;
• Unable to understand the research nature of the research or have not obtained informed consent;
• Thrombocytopenia caused by other causes (chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
• Patients with unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent history (within 1 year of screening) of myocardial infarction;
• Those with a history of blood disease or tumor bone marrow infiltration;
• Those who received simultaneous radiotherapy and those who received pelvic radiotherapy in the past;
• Arterial or venous thrombotic events within the past 6 months;
• There are currently uncontrollable infections;
• Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;
• Need emergency treatment, such as superior vena cava syndrome, spinal cord compression;
• 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;
• 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;
• Abnormal renal function: serum creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft-Gault formula);
• \. 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

hetrombopag

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• min yan

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

min yan

CONTACT

15713857388; ym200678@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 27, 2022
• Study Start: August 19, 2022
• Primary Completion: June 25, 2025
• Study Completion: August 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)