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
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.
- 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