HER-2 positive breast cancer
Conditions
Interventions
Experimental group:oral herombopag
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-80 years old (inclusive of 18 and 80), female; 2.ECOG 0-1; 3.Histologically confirmed invasive breast cancer, which is positive HER-2 expression as confirmed by pathological examination;The clinical stage at the time of diagnosis was T1-4/N0-3/M0 (patients with T1a/bN0 tumors were excluded); 4.have Completed preoperative systemic chemotherapy and HER-2 targeted therapy; 5.The first time to receive T-DM1 treatment with normal platelet count; 6.During the screening period, no TPO-RAs drugs were used within the previous 2 weeks, and no platelet transfusion or other platelet-boosting treatments were received; 7.The major organs' functional must meet the following requirements: Blood routine examination: Absolute neutrophil count>=1.5×10^9/L, hemoglobin>=90g/L, platelet counts>=100×10^9/L; blood biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase are within the upper limit of the normal reference range, bilirubin = 55%.The size of the spleen was within the normal range as determined by imaging tests, and there were no clinical manifestations of splenic hyperfunction (such as thrombocytopenia); 8.For female patients who have not undergone menopause or sterilization surgery: During the treatment period until to at least 7 months after the last administration of the treatment, it is agreed to use an effective contraceptive method; 9.Voluntarily participate in this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Stage IV (metastatic) breast cancer; 2.Evidence of obvious macroscopic residual lesions or disease recurrence in the clinical setting after preoperative treatment and surgery; 3.Progression during the preoperative systemic treatment period; 4.Having a history of other malignant tumors in the past 5 years; 5.Currently, there is grade 2 or higher peripheral neuropathy according to the NCI CTCAE (version 4.0); 6.Has previously received treatment with T-DM1; 7.Currently suffering from severe and uncontrolled systemic diseases other than breast cancer; 8.Any known active liver disease which aused by HBV, HCV, autoimmune liver disease or sclerosing cholangitis , accompanied by a severe infection that requires treatment and is not under control, or a known infection with HIV etc; 9.Those who have a history of allergic reactions to any component of this medication are excluded from this program; 10.Pregnant female patients, Female patients who are fertile and whose baseline pregnancy test is positive, All reproductive-aged patients who were unwilling to take effective contraceptive measures throughout the entire trial period and within 7 months after the last administration of the study medication; 11.Patients with blood diseases who the researchers believe that it should not be included. 12.The researchers believe that the patient is not suitable for this study by any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No grade 3 or higher thrombocytopenia occurred during the medication period;There is no adjustment of T-DM1 dose due to thrombocytopenia(Delay of = 5 days, and/or dose reduction of = 20%, treatment suspension or termination, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events;The incidence and duration of =2-grade PLT reduction in the first cycle;The proportion of subjects whose next cycle of T-DM1 administration was suspended or reduced due to thrombocytopenia;Safety;The incidence and duration of grade 2 or higher PLT reduction throughout the T-DM1 treatment period; | — |
Countries
China
Contacts
Public ContactLuo Ting
West China Hospital of Sichuan University
Outcome results
None listed