Breast cancer
Conditions
Interventions
Test group:Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent combined with pyrrolidine maleate
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Signed Informed Consent Form(ICF); (2)Women or man aged 18 to 75 years; (3)Breast cancer with unresectable locally advanced or metastatic disease diagnosed by cytology or histology; (4)Subjects who had received =50% detected by echocardiography during screening; (12)Patients have recovered from any AE (grade =1.5*10^9/L; Platelet >=100*10^9/L; Hemoglobin >=90 g/L; Liver function: total bilirubin =3 months.
Exclusion criteria
Exclusion criteria: (1) patients who are known to be allergic to any of the active ingredients or excipients of RC48-ADC or pyrotinib, or who are judged by the investigator to be unsuitable for RC48-ADC or pyrtinib treatment; (2) patients previously treated with T-DM1 or other HER2-ADC drugs or HER2 tyrosine kinase inhibitors (such as lapatinib, pyrotinib, etc.); (3) Patients with another malignant tumor in the past 5 years were not eligible. (Exceptions: malignant tumors such as cervical cancer in situ and non-melanoma skin cancer receiving curative treatment were eligible.) (4) Patients with primary central nervous system (CNS) malignant tumors or CNS metastases that had failed local treatment were not eligible. (Exceptions: asymptomatic brain metastases or clinically stable patients who did not require steroids or other treatments for brain metastases for >=28 days before the first administration of the investigational drug were eligible.) (5) Patients with interstitial lung disease requiring steroid therapy, drug-induced interstitial lung disease, radiation pneumonitis, or clinically active interstitial lung disease suggested by any evidence; (6) Subjects with cardiac insufficiency, including but not limited to subjects with congestive heart failure, transmural myocardial infarction, angina requiring medical treatment, clinically significant valvular heart disease and high-risk arrhythmia, or abnormal QTc on ECG during screening and clinically significant (at rest, QTc > 450 msec (male) or QTc > 470 msec (female) after ECG correction); (7) Subjects with evidence of severe or uncontrolled systemic disease (such as unstable or uncompensated respiratory, cardiac, hepatic or renal disease) according to the investigator's judgment; (8) Patients with any uncontrolled infection or other circumstances that may limit adherence to the study or interfere with the evaluation; (9) Patients with hepatitis B surface antigen positive and HBV DNA>=ULN, or positive of hepatitis C virus antibody or human immunodeficiency virus antibody test results; (10) Pregnant or lactating women; (11) Women of reproductive age who are unwilling or unable to use an acceptable method of contraception for the entire treatment period of the trial and within 8 months after the last dose of the trial product. (Women of reproductive age included: any who had had menarche, and those who had not had artificial sterilization [hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or premenopausal or male subjects) ; (12) Patients with any mental or cognitive impairment that may limit the understanding and implementation of informed consent; (13) Other conditions considered by the investigator to be inappropriate for participation in the trial, such as poor adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;clinical benefit rate;Duration of response; | — |
Countries
China
Contacts
Public ContactXin Zhou
Chongqing University Cancer Hospital
Outcome results
None listed