CTIT-Chemotherapy Induced ThrombocytopeniaPhase 2NCT07243418
Hetrombopag for the Prevention of ADC-Induced Thrombocytopenia in Breast Cancer: An Exploratory, Dual-Cohort, Phase 2 Study
A Phase 2 study testing herombopag olamine tablets in people with CTIT-Chemotherapy Induced Thrombocytopenia and Breast Cancer, run by Fujian Cancer Hospital.
Trial summary
The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary/secondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CTIT-Chemotherapy Induced Thrombocytopenia, Breast Cancer
- What is being tested?
- herombopag olamine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 -75 years old, gender not limited.
- 2. Breast cancer patients diagnosed by histopathological or cytological examination;
- 3. Cohort 1: Planned to receive ADC drug treatment; Cohort 2: Patients who received ADC drug treatment in the previous chemotherapy cycle and had a minimum PLT value of less than 75*109/L are expected to maintain the same chemotherapy regimen for ≥2 cycles.
- 4. Expected survival period ≥12 weeks;
- 5. Physical condition ECOG PS score: 0-2 points;
- 6. The laboratory inspection indicators meet the following requirements:
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- Renal function: Cr≤UNL (upper limit of normal) ×1.5, endogenous creatinine clearance rate (Ccr) ≥55 ml/min;
- Liver function: Total bilirubin ≤ULN×1.5; ALT and AST≤ULN×3; If it is intrahepatic cholangiocarcinoma or liver metastasis, the total bilirubin shall not exceed three times the upper limit of normal, and the transaminase shall not exceed five times the upper limit of normal.
- Coagulation function: The international normalized ratio of prothrombin time is ≤ULN×1.5, and some prothrombin times are within the normal range.
- 7. Women of childbearing age agree to use contraception during the study period and for six months after the end of the study. And not a lactating patient; Male patients who agreed to contraception during the study period and for 6 months after the end of the study;
- 8. Those who have not participated in other drug clinical trials within 4 weeks prior to enrollment;
- 9. The subjects can understand the situation of this study and voluntarily sign the informed consent form.
- 10. No serious complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever > 38℃;
- 11. Those with good expected compliance can follow up on the therapeutic effect and adverse reactions as required by the protocol.
Who cannot join
- 1. Screening or baseline platelet value ≤10×109/L;
- 2. Patients who are currently taking pyrotinib, dalciclib or other CDK4/6 class drugs
- 3. Thrombocytopenia caused by non-tumor treatment occurred within 6 months before screening, including but not limited to liver cirrhosis with hypersplenism, infection and bleeding, etc.
- 4. Suffering from other hematopoietic system diseases except for thrombocytopenia caused by anti-tumor therapy, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome, etc.
- 5. Combined bone marrow invasion or bone marrow metastasis;
- 6. Had received radiotherapy for the pelvis, spine and bone irradiation within 3 months before screening:
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- 7. Any history of arterial or venous thrombosis within 6 months prior to the screening;
- 8. There were severe clinical manifestations of bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening;
- 9. Patients with severe cardiovascular diseases (such as NYHA cardiac function score III-IV), arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, after coronary stent implantation, angioplasty, and after coronary artery bypass grafting within 6 months prior to screening;
- 10. Brain tumors or brain metastases;
- 11. When the absolute value of neutrophils is less than 1.0×109/L and hemoglobin is less than 80g/L, the use of granulocyte colony-stimulating factor and red blood cell, EPO infusion therapy that conforms to clinical routine is allowed.
- 12. Significantly abnormal liver function: For patients without liver metastasis, ALT/AST > 3ULN (upper limit of normal value), and TBIL > 3ULN; Patients with liver metastasis have ALT/AST≥5ULN and TBIL≥5ULN.
- 13. Abnormal renal function: Serum creatinine ≥1.5ULN or eGFR≤60 ml/min (Cockcroft-Gault formula)
- 14. Platelet transfusion was received within 2 days before enrollment;
- 15. Received treatment with human recombinant thrombopoietin (rhTPO), human recombinant interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatracopag) within 10 days before screening;
- 16. Patients who are known or expected to be allergic to or intolerant to the active ingredients or excipients of heltrombopag ethanolamine tablets (excipients include: cellulose-lactose, low-substitution hydroxypropyl cellulose, magnesium stearate, film-coated premixes);
- 17. Pregnant or lactating women;
- 18. Those who were considered unsuitable for inclusion by the researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dual-cohort, Single-arm, Exploratory Phase II Clinical Study of Hetrombopag for Primary/Secondary Prevention of Thrombocytopenia Induced by ADC Drugs in Breast Cancer
The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary/secondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. This study is a two-cohort, single-arm, open-label, exploratory clinical trial for the prevention of thrombocytopenia caused by ADC drug treatment for breast cancer. This research was supported by Fujian Cancer Hospital. The protocol has been reviewed by the Ethics Committee of Fujian Cancer Hospital, which has agreed to conduct this clinical study.
- Being tested
- herombopag olamine tablets
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herombopag olamine tabletsDrug
Starting from day 1 after chemotherapy, oral administration ofherombopag olamine tablets at a dose of 5mg per day (the initial dose) was administered for 14 consecutive days. Blood routine tests of the subjects were collected on days 7, 10, and 14 respectively, and the dose of herombopag olamine tablets was adjusted according to PLT
| Study group | Role | What they receive |
|---|---|---|
| Primary prevention | Experimental | Not described Receives: Drug: herombopag olamine tablets |
| Secondary prevention | Experimental | Not described Receives: Drug: herombopag olamine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of Grade 3 and above Cancer Therapy - Induced Thrombocytopenia (CTIT)
Measured: During the period of oral medication (14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTIT-Chemotherapy Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243418
- Sponsor's protocol ID
- HQBP-BC-01
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-cohort, Single-arm, Exploratory Phase II Clinical Study of Hetrombopag for Primary/Secondary Prevention of Thrombocytopenia Induced by ADC Drugs in Breast Cancer
- ClinicalTrials.gov ID
- NCT07243418
- Acronym / sponsor ID
- HQBP-BC-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary/secondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. This study is a two-cohort, single-arm, open-label, exploratory clinical trial for the prevention of thrombocytopenia caused by ADC drug treatment for breast cancer. This research was supported by Fujian Cancer Hospital. The protocol has been reviewed by the Ethics Committee of Fujian Cancer Hospital, which has agreed to conduct this clinical study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary prevention | Experimental | Drug: herombopag olamine tablets |
| Secondary prevention | Experimental | Drug: herombopag olamine tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Age: 18 -75 years old, gender not limited.
- 2. Breast cancer patients diagnosed by histopathological or cytological examination;
- 3. Cohort 1: Planned to receive ADC drug treatment; Cohort 2: Patients who received ADC drug treatment in the previous chemotherapy cycle and had a minimum PLT value of less than 75*109/L are expected to maintain the same chemotherapy regimen for ≥2 cycles.
- 4. Expected survival period ≥12 weeks;
- 5. Physical condition ECOG PS score: 0-2 points;
Key exclusion criteria (18 listed)
- 1. Screening or baseline platelet value ≤10×109/L;
- 2. Patients who are currently taking pyrotinib, dalciclib or other CDK4/6 class drugs
- 3. Thrombocytopenia caused by non-tumor treatment occurred within 6 months before screening, including but not limited to liver cirrhosis with hypersplenism, infection and bleeding, etc.
- 4. Suffering from other hematopoietic system diseases except for thrombocytopenia caused by anti-tumor therapy, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome, etc.
- 5. Combined bone marrow invasion or bone marrow metastasis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herombopag olamine tabletsStarting from day 1 after chemotherapy, oral administration ofherombopag olamine tablets at a dose of 5mg per day (the initial dose) was administered for 14 consecutive days. Blood routine tests of the subjects were collected on days 7, 10, and 14 respectively, and the dose of herombopag olamine tablets was adjusted according to PLT | Drug | Primary prevention, Secondary prevention |
Primary outcome
The incidence rate of Grade 3 and above Cancer Therapy - Induced Thrombocytopenia (CTIT)
Time frame: During the period of oral medication (14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing herombopag olamine tablets in people with CTIT-Chemotherapy Induced Thrombocytopenia and Breast Cancer, run by Fujian Cancer Hospital.
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 14 inclusion and 18 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nani Li (+86 136 9688 5660, 244831271@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of Grade 3 and above Cancer Therapy - Induced Thrombocytopenia (CTIT) (time frame: During the period of oral medication (14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.