ThrombocytopeniaPhase 2NCT07257809
Herombopag Treated T-DM1 Induced Platelet Reduction
A Phase 2 study testing Herombopag Olamine Tablets in people with Thrombocytopenia, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thrombocytopenia
- 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
- 56 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2025to 26 Sep 2027
- 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
- Age 18-75 years, any gender;
- Pathologically diagnosed with breast cancer based on histological or cytological examination, and previously treated with neoadjuvant anti-HER-2 therapy followed by T-DM1 adjuvant therapy;
- Experienced grade 2 or higher tumor treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to ≥100 × 109/L and ≤200 × 109/L prior to the next treatment;
- ECOG performance status score: 0-2;
- Planned to undergo at least two additional treatment cycles including T-DM1 administration, with the dose of T-DM1 in the current cycle consistent with the previous cycle;
- Expected survival of ≥12 weeks and able to tolerate the current treatment regimen for at least two cycles or more;
- Expected to have good compliance, able to follow up on treatment efficacy and adverse reactions as required by the protocol.
Who cannot join
- A history of other malignant tumors diagnosed within the past 3 years;
- Patients with mental or neurological disorders who are unable to cooperate;
- Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplantation;
- Patients with hematopoietic system disorders other than chemotherapy-induced thrombocytopenia (CTIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome;
- Patients with a history of any arterial or venous thrombotic events within the past 6 months prior to screening;
- Severe bleeding manifestations within 2 weeks prior to screening, such as gastrointestinal or central nervous system bleeding;
Show all 10Show fewer
- Participation in a clinical trial of the same type of drug within 4 weeks prior to enrollment;
- Pregnant or lactating women;
- Patients with a history of hypersensitivity to the study drug;
- Patients deemed ineligible by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Tao Qin, MD, 86-02034071337, qintao5471@163.com
About this study
Official title: A Multicenter, Single-arm Exploratory Clinical Study Evaluating the Efficacy and Safety of T-DM1 in Patients With Breast Cancer Who Developed Thrombocytopenia.
This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention.
- Conditions
- Thrombocytopenia
- Being tested
- Herombopag Olamine Tablets
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herombopag Olamine TabletsDrug
Herombopag 7.5 mg po qd，d1-14
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Herombopag， initial dose 7.5 mg po qd d1-14 Receives: Drug: Herombopag Olamine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of grade I thrombocytopenia according to CTCAE4.0
The proportion of patients with platelet counts <100 × 109/L according to CTCAE4.0
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (4)
the proportion of salvage platelet transfusion therapy
Proportion of patients requiring platelet transfusion therapy during treatment
Measured: From enrollment to the end of treatment at 6 weeks
time to platelet counts ≥100 × 109/L
Median time to achieve and maintain platelet counts ≥100 × 109/L from the start of Hetrombopag until the next treatment cycle;
Measured: From enrollment to the end of treatment at 6 weeks
Proportion of T-DM1with unexpected administration
Proportion of patients who experienced delay, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia
Measured: From enrollment to the end of treatment at 6 weeks
proportion of adverse events
According to CTC AE 4.0 to evaluate profile of adverse events
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start13 Oct 2025
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinduo Zeng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yinduo Zeng, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257809
- Sponsor's protocol ID
- HQBP-IIT-2025
- Status last verified
- Oct 2025
- First submitted
- 3 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm Exploratory Clinical Study Evaluating the Efficacy and Safety of T-DM1 in Patients With Breast Cancer Who Developed Thrombocytopenia.
- ClinicalTrials.gov ID
- NCT07257809
- Acronym / sponsor ID
- HQBP-IIT-2025
- Conditions
- Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Sep 2027 (estimated)
- First posted
- 2 Dec 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.
This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: Herombopag Olamine TabletsHerombopag， initial dose 7.5 mg po qd d1-14 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years, any gender;
- Pathologically diagnosed with breast cancer based on histological or cytological examination, and previously treated with neoadjuvant anti-HER-2 therapy followed by T-DM1 adjuvant therapy;
- Experienced grade 2 or higher tumor treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to ≥100 × 109/L and ≤200 × 109/L prior to the next treatment;
- ECOG performance status score: 0-2;
- Planned to undergo at least two additional treatment cycles including T-DM1 administration, with the dose of T-DM1 in the current cycle consistent with the previous cycle;
Key exclusion criteria (10 listed)
- A history of other malignant tumors diagnosed within the past 3 years;
- Patients with mental or neurological disorders who are unable to cooperate;
- Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplantation;
- Patients with hematopoietic system disorders other than chemotherapy-induced thrombocytopenia (CTIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome;
- Patients with a history of any arterial or venous thrombotic events within the past 6 months prior to screening;
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 TabletsHerombopag 7.5 mg po qd，d1-14 | Drug | Treatment group A |
Primary outcome
Proportion of grade I thrombocytopenia according to CTCAE4.0
Time frame: From enrollment to the end of treatment at 6 weeks
The proportion of patients with platelet counts <100 × 109/L according to CTCAE4.0
4 secondary outcomes
the proportion of salvage platelet transfusion therapy
Time frame: From enrollment to the end of treatment at 6 weeks
time to platelet counts ≥100 × 109/L
Time frame: From enrollment to the end of treatment at 6 weeks
Proportion of T-DM1with unexpected administration
Time frame: From enrollment to the end of treatment at 6 weeks
proportion of adverse events
Time frame: From enrollment to the end of treatment at 6 weeks
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 2 Dec 2025.
Related trials for Thrombocytopenia
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingPhase 3
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal Alloimmune
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Preliminary Effectiveness of Induced Pluripotent Stem Cell-derived Platelets in Patients With Thrombocytopenia Caused by Allogeneic Hematopoietic Stem Cell Transplantation
Thrombocytopenia
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.
Yinduo Zeng, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herombopag Olamine Tablets in people with Thrombocytopenia, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Tao Qin, MD (86-02034071337, qintao5471@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of grade I thrombocytopenia according to CTCAE4.0 (time frame: From enrollment to the end of treatment at 6 weeks). 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 2 Dec 2025.