Exploratory Study of Advanced Breast Cancer in HER2 Posit... | NCT04681287

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
inetetamab and PD-1 inhibitor combined with chemotherapy.	Experimental		Drug: inetetamab and PD-1 inhibitor combined with chemotherapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inetetamab and PD-1 inhibitor combined with chemotherapy.	Drug	Chemotherapy selected by doctors: albumin bound paclitaxel, vinorelbine, gemcitabine, capecitabine, and aribrin were administered according to clinical routine; The first dose was 8 mg / kg, followed by 6 mg / kg, once every 3 weeks PD-1 inhibitor 200mg D1 every 3 weeks as a cycle Treatment to disease progression or toxicity intolerance, or death from any cause. The efficacy was evaluated every 2 cycles and adverse events were recorded. After 4-6 cycles of treatment, if the patient is intolerable to chemotherapy for any reason, the chemotherapy can be stopped and the combination of inistumab and PD-1 can be continued.

Measure	Description	Time Frame
progression-free survival rate at 3 months（PFS rate）	The rate of events from date of randomization until observation of disease progression or death from any cause at 3 months	Estimated up to 3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18-75 years old female patients;
The results showed that HER-2 was positive at least once in patients with recurrent and metastatic breast cancer confirmed by pathology: HER-2 (+ + +) was confirmed by immunohistochemistry; if HER-2 (+ +), fish / CISH was required to confirm HER-2 amplification;
Previous treatment (including neoadjuvant, adjuvant and rescue therapy) received at least trastuzumab and TKIs;
It is allowed that the previous rescue chemotherapy does not exceed 3 lines, and must be disease progression before being included in the study; it is allowed to receive rescue endocrine therapy; chemotherapy allows to receive one of the chemotherapy of albumin binding paclitaxel, vinorelbine, gemcitabine, capecitabine and aribrin;
At least one target lesion can be defined according to RECIST 1.1, and the target lesion has not received radiotherapy (or other local treatment), unless it progresses after the treatment;
Before the study, chemotherapy and targeted therapy must be completed for at least 2 weeks, and endocrine therapy and antiangiogenic drug treatment for 1 week;
ECoG PS: 0-1 points;
The expected survival time was more than 3 months;
The function of the main organs is normal, that is to say, it meets the following standards:

1）Blood routine examination standard should meet (no blood transfusion and blood products within 14 days, not used G-CSF and other hematopoietic stimulating factors were corrected)

Hb≥90g/L；

②ANC≥1.5×109/L；

③PLT≥75×109/L； 2）Biochemical examination should meet the following standards:
TBIL<1.5×ULN；
- Alt, AST < 2.5 × ULN, liver metastasis < 5 × ULN;
  - Bun and Cr ≤ 1 × ULN or creatinine clearance rate ≥ 50ml / min (Cockcroft Gault formula).
    
    10.Women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the results are negative, and they are willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug; 11.The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion Criteria:

Symptomatic, uncontrolled brain metastases or leptomeningeal metastases.However, patients with stable condition after local treatment for 4 weeks could be enrolled;
There was effusion in the third space which could not be controlled by drainage or air pressure;
Interstitial lung disease, non-infectious pneumonia, memory pneumonia, pulmonary fibrosis and other diseases;
Those who have a history of live attenuated vaccine vaccination in the 28 days before the first study medication or are expected to receive live attenuated vaccine in the study;
Other malignant tumors in the past 3 years, excluding cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma of skin;
Patients with hypertension who could not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
Suffering from serious or uncontrollable diseases, including but not limited to:

1) Active viral infection, such as HIV, HBV active phase (HBsAg positive and HBV-DNA ≥ 103, hepatitis C antibody positive); 2) Previous severe cardiovascular diseases: uncontrollable hypertension; myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. in the first six and six patients; according to NYHA standard, grade III ~ IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50% according to NYHA standard; 8.Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 9.According to the judgment of the researchers, there are other patients with accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study; 10.Pregnant or lactating women; 11.The researchers think it is not suitable for the participants.