HER2-positive Breast CancerNCT07198672
Primary Prevention of Thrombocytopenia Associated With T-DM1 Therapy in HER2 Positive Breast Cancer With Herombopag
A study testing Herombopag in people with HER2-positive Breast Cancer, run by Zhenzhen Liu.
Trial summary
Ado-trastuzumab emtansine (T-DM1) demonstrates favorable efficacy in breast cancer treatment but is frequently associated with thrombocytopenia. Multiple studies indicate that Asian populations face a higher risk of developing thrombocytopenia during T-DM1 therapy, with incidence rates ranging from 52.5% to 69.8% and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Herombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2025to 31 Oct 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age ≥18 years;
- Histopathologically or cytologically confirmed diagnosis of breast cancer;
- Tumor tissue confirmed as HER2-positive, defined as immunohistochemistry (IHC) showing +++, or IHC++ with fluorescence in situ hybridization (FISH) demonstrating HER2-positive status;
- Planned to receive T-DM1 regimen based on clinical judgment;
- ECOG PS score: 0-2;
- Expected survival greater than 12 weeks;
- Adequate organ and bone marrow function.
Who cannot join
- A confirmed history of severe allergic reactions to the active ingredients or excipients of the therapeutic drug;
- Presence of other underlying diseases or comorbidities causing thrombocytopenia, such as aplastic anemia, immune thrombocytopenia, myelodysplastic syndrome, etc.;
- Individuals with hereditary bleeding disorders, coagulation dysfunction, high bleeding risk, or a history of thrombotic events (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months prior to initial medication use;
- Individuals with uncontrolled hypertension and a history of hypertensive crisis or hypertensive encephalopathy;
- Pregnant or lactating women;
- Presence of multiple factors affecting oral drug absorption, such as dysphagia, nausea/vomiting, chronic diarrhea, or intestinal obstruction;
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- History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;
- Currently participating in interventional clinical research treatment, or having received other investigational drugs or devices within 4 weeks prior to first dosing (individuals who failed screening for other clinical trials may be included in this study);
- Any other factors deemed by the investigator to increase study risk, affect patient compliance with the protocol, or impact the patient's ability to complete the trial, such as physiological or psychological conditions that make participation in this study inappropriate;
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: A Multicenter, Single-arm, Exploratory Clinical Study of Herombopag Olamine Tablets for the Primary Prevention of Treatment-related Thrombocytopenia in HER2-positive Breast Cancer Patients Receiving T-DM1 Therapy
Ado-trastuzumab emtansine (T-DM1) demonstrates favorable efficacy in breast cancer treatment but is frequently associated with thrombocytopenia. Multiple studies indicate that Asian populations face a higher risk of developing thrombocytopenia during T-DM1 therapy, with incidence rates ranging from 52.5% to 69.8% and ≥Grade 3 rates between 29.8% and 45.0%. Severe thrombocytopenia not only increases bleeding risks but may also necessitate T-DM1 dose delays or reductions, thereby compromising treatment efficacy and diminishing patient survival and quality of life. Herombopag selectively binds to the transmembrane region of TPO-R, activating TPO-R-dependent STAT and MAPK signaling pathways. This effectively stimulates megakaryocyte proliferation and differentiation, promoting thrombopoiesis. However, high-level evidence supporting the use of Herombopag for primary prevention of T-DM1-induced thrombocytopenia in breast cancer remains lacking.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Herombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerombopagDrug
Each T-DM1 treatment cycle typically lasts 3 weeks, with prophylactic administration of eltrombopag continuing until 21 days after the end of that T-DM1 treatment cycle. Oral administration of eltrombopag ethanolamine tablets begins on the evening of the first day of each T-DM1 treatment cycle, starting at a dose of 7.5 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Herombopag Group | Experimental | Preventive treatment with eltrombopag should be initiated on the evening of the first day of each T-DM1 treatment cycle (typically 3 weeks). Eltrombopag 7.5 mg (initial dose) should be administered orally once daily for a maximum duration of 21 days. Receives: Drug: Herombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thrombocytopenia (<100 × 10⁹/L)
PLT <100 × 10⁹/L
Measured: up to 6 cycles (each cycle is 21 days)
Secondary outcomes (2)
The time of the first occurrence of thrombocytopenia (<100 × 10⁹/L);
Time at which PLT < 100 × 10⁹/L occurs
Measured: up to 6 cycles (each cycle is 21 days)
Incidence of AEs
Record the occurrence of adverse events during the study period
Measured: up to 6 cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start31 Oct 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenzhen Liu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198672
- Sponsor's protocol ID
- HN-CTIT-HQ-001
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Exploratory Clinical Study of Herombopag Olamine Tablets for the Primary Prevention of Treatment-related Thrombocytopenia in HER2-positive Breast Cancer Patients Receiving T-DM1 Therapy
- ClinicalTrials.gov ID
- NCT07198672
- Acronym / sponsor ID
- HN-CTIT-HQ-001
- Conditions
- HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zhenzhen LiuOther government
- Study start
- 31 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 30 Sep 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.
Ado-trastuzumab emtansine (T-DM1) demonstrates favorable efficacy in breast cancer treatment but is frequently associated with thrombocytopenia. Multiple studies indicate that Asian populations face a higher risk of developing thrombocytopenia during T-DM1 therapy, with incidence rates ranging from 52.5% to 69.8% and ≥Grade 3 rates between 29.8% and 45.0%. Severe thrombocytopenia not only increases bleeding risks but may also necessitate T-DM1 dose delays or reductions, thereby compromising treatment efficacy and diminishing patient survival and quality of life. Herombopag selectively binds to the transmembrane region of TPO-R, activating TPO-R-dependent STAT and MAPK signaling pathways. This effectively stimulates megakaryocyte proliferation and differentiation, promoting thrombopoiesis. However, high-level evidence supporting the use of Herombopag for primary prevention of T-DM1-induced thrombocytopenia in breast cancer remains lacking.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herombopag Group | Experimental | Drug: HerombopagPreventive treatment with eltrombopag should be initiated on the evening of the first day of each T-DM1 treatment cycle (typically 3 weeks). Eltrombopag 7.5 mg (initial dose) should be administered orally once daily for a maximum duration of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, age ≥18 years;
- Histopathologically or cytologically confirmed diagnosis of breast cancer;
- Tumor tissue confirmed as HER2-positive, defined as immunohistochemistry (IHC) showing +++, or IHC++ with fluorescence in situ hybridization (FISH) demonstrating HER2-positive status;
- Planned to receive T-DM1 regimen based on clinical judgment;
- ECOG PS score: 0-2;
Key exclusion criteria (9 listed)
- A confirmed history of severe allergic reactions to the active ingredients or excipients of the therapeutic drug;
- Presence of other underlying diseases or comorbidities causing thrombocytopenia, such as aplastic anemia, immune thrombocytopenia, myelodysplastic syndrome, etc.;
- Individuals with hereditary bleeding disorders, coagulation dysfunction, high bleeding risk, or a history of thrombotic events (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months prior to initial medication use;
- Individuals with uncontrolled hypertension and a history of hypertensive crisis or hypertensive encephalopathy;
- Pregnant or lactating women;
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 |
|---|---|---|
| HerombopagEach T-DM1 treatment cycle typically lasts 3 weeks, with prophylactic administration of eltrombopag continuing until 21 days after the end of that T-DM1 treatment cycle. Oral administration of eltrombopag ethanolamine tablets begins on the evening of the first day of each T-DM1 treatment cycle, starting at a dose of 7.5 mg once daily. | Drug | Herombopag Group |
Primary outcome
Incidence of thrombocytopenia (<100 × 10⁹/L)
Time frame: up to 6 cycles (each cycle is 21 days)
PLT <100 × 10⁹/L
2 secondary outcomes
The time of the first occurrence of thrombocytopenia (<100 × 10⁹/L);
Time frame: up to 6 cycles (each cycle is 21 days)
Incidence of AEs
Time frame: up to 6 cycles (each cycle is 21 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 30 Sep 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 study testing Herombopag in people with HER2-positive Breast Cancer, run by Zhenzhen Liu.
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 7 inclusion and 9 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 30 Sep 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.
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 zhenzhen Liu, M.D. (13603862755, zlyyliuzhenzhen0800@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thrombocytopenia (<100 × 10⁹/L) (time frame: up to 6 cycles (each cycle is 21 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 30 Sep 2025.