Status:
UNKNOWN
Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone.
Lead Sponsor:
Henan Cancer Hospital
Conditions:
HER2 Positive Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This study plans to explore the efficacy and safety of chemotherapy combined with inetetamab and PD-1 inhibitors in HER2 positive advanced breast cancer who failed to receive trastuzumab and TKIs, and...
Eligibility Criteria
Inclusion
- 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).
- 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
- 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.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04681287
Start Date
April 23 2021
End Date
December 30 2024
Last Update
September 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Henan cancer hospital
Zhengzhou, Henan, China, 450008