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Breast CancerPhase 2NCT05394285

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

A Phase 2 study testing Hetrombopag in people with Breast Cancer, run by Henan Cancer Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Hetrombopag
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
21 Sep 2022to 1 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • Women who are pregnant or breastfeeding;
  • Unable to understand the research nature of the research or have not obtained informed consent;
  • The investigator judges other circumstances that are not suitable for inclusion in the study;
  • 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;
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  • 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);
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

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

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.

Read the 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
Being tested
Hetrombopag
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HetrombopagDrug

    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.

Study groups in NCT05394285
Study groupRoleWhat they receive
hetrombopag Olamine tabletsExperimentalThe 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.
Receives: Drug: Hetrombopag
rhTPOOtherThe 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.
Receives: Drug: Hetrombopag

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)

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

    The response rate defined as the treatment 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).

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

  2. The lowest platelet value after anti-tumor treatment;

    The lowest platelet value after anti-tumor treatment;

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

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

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

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

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

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

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

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

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

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

  6. latelet recovery to the highest value after anti-tumor treatment;

    latelet recovery to the highest value after anti-tumor treatment;

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

  7. the incidence of adverse events;

    the incidence of adverse events;

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start21 Sep 2022
  3. Primary completion25 Jun 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394285
Sponsor's protocol ID
HNCH-MBC10
Status last verified
Mar 2025
First submitted
30 Apr 2022
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hetrombopag in people with Breast Cancer, run by Henan Cancer Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The response rates to platelet-raising therapy in prevention stage (time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05394285.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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