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Recruiting Phase 2

Herombopag Treated T-DM1 Induced Platelet Reduction

About this study

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.

Condition
Thrombocytopenia
Tested
Herombopag Olamine Tablets
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 22

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Thrombocytopenia
  • 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 efficacy 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 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;
  • 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.

Where

1 site, 1 recruiting

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.