her2-positive breast cancer project initiated by investigators

Conditions: Breast Cancer

Summary: this study will assess the objective response rate (orr), safety, progression-free survival (pfs) , overall survival (os), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (dcr), clinical benefit rate (cbr), duration of response (dor) and time to response (ttr). injection of a166 for her2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous adc drug therapy.


Eligibility criteria:
inclusion criteria: * 1. male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form; 2. breast cancer patients by histopathology and/or cytology documented, including: a) participants with unresectable locally advanced or metastatic breast cancer; b) evaluated or tested as her2-positive expression. the definition of her2 positive in this study: immunohistochemistry (ihc) was 2+ and confirmed by fluorescence in situ hybridization (fish), or ihc was 3+; 3. have received at least 3 targeted therapies for locally advanced or metastatic disease, including: 1. disease progression after receiving at least 1 trastuzumab-containing (including a biosimilar of trastuzumab on the market)-based treatment; 2. after receiving at least one anti-her2 tyrosine kinase inhibitor (lapatinib or pyrrotinib)-based treatment plan, the disease progresses or cannot tolerate toxic and side effects; 3. the disease progresses or cannot tolerate toxic and side effects after receiving treatment with antibody-conjugated drugs targeting her2 (such as t-dm1 or other adcs); note: adjuvant therapy and anti-her2 therapy used in the neoadjuvant treatment stage before radical treatment are not counted, but recurrence or metastasis occurs during the last anti-her2 medication period or within one year after the end, it can be regarded as a plan. 4. have previously received taxanes to treat breast cancer; exclusion criteria: * 1. serious or uncontrollable heart diseases that require treatment, including: 1. congestive heart failure graded 3 or 4 by the new york college of cardiology (nyha); 2. unstable angina pectoris that cannot be controlled by drugs; 3. myocardial infarction occurred within 6 months before the first administration of the study treatment; 4. severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia); 2. baseline measurement, qtc interval, male\> 450 msec, female\> 470 msec; 3. clinically active interstitial lung disease; 4. patients with primary central nervous system (cns) malignant tumors or cns metastases that have failed local treatment; for asymptomatic brain metastases, or with stable clinical symptoms and no need for steroids and other brain metastases within 4 weeks before the first administration of the trial drug treated patients can be included in the group; 5. those who are known to have a history of hypersensitivity to other monoclonal antibodies or allergic to a166 and its components for injection; 6. those who have permanently discontinued trastuzumab due to any toxicity;

Keywords: her2-positive breast cancer