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New treatment option for Thrombocytopenia
Official title Herombopag Treated T-DM1 Induced Platelet Reduction
ClinicalTrials.gov ID: NCT07257809
What this study is testing
What is Herombopag Olamine Tablets?
Herombopag Olamine Tablets is an investigational medicine, being studied as a potential treatment for thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Inclusion：
- 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...
- Experienced grade 2 or higher tumor treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to...
- ECOG performance status score: 0-2;
See the full eligibility criteria
- Inclusion：
- 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 how well it works and adverse reactions as required by the protocol. Exclusion:
- 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...
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.