Primary Prevention of Thrombocytopenia Associated With T-DM1 Therapy in HER2 Positive Breast Canc… (NCT07198672) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Primary Prevention of Thrombocytopenia Associated With T-DM1 Therapy in HER2 Positive Breast Cancer With Herombopag
45 participantsStarted 2025-10-31
Plain-language 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 ≥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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
. 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);