Breast cancer
Conditions
Interventions
Experimental group:pyrotinib combined with ARX788 neoadjuvant therapy
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 75 years (the maximum age of the subjects in the phase 3 pyrotinib study is 75 years old, and there is no safety data on the use of drugs in higher age groups); 2. Breast cancer meets the following criteria: (1) Histologically confirmed invasive breast cancer; (2) Tumor staging: patients with stage II-III meeting the AJCC 8th edition criteria; (3) Patients who have received neoadjuvant therapy with trastuzumab and pertuzumab-containing regimens and are assessed as SD (0-20% increase), PD, inoperable or not meeting the requirements for breast conservation during neoadjuvant therapy ; (4) Failure to meet the requirements for breast conservation is defined as those who do not meet the following criteria: the tumor size belongs to T1 and T2 stages, the breast has an appropriate volume, the proportion of the tumor to the breast volume is appropriate, and the early breast cancer patients can maintain a good breast shape after surgery; (5) Definition of inoperability: patients with stage IIIB-IIIC assessed by the investigator during neoadjuvant therapy. 3. HER2-positive breast cancer confirmed by pathological examination, defined as IHC3+ or FISH+; 4. ECOG functional status score 0-1 points; 5. The functional level of the organ must meet the following requirements: (1) Bone marrow function: absolute neutrophil count (ANC) >=1.5x10^9/L (no growth factor used within 14 days); platelet count >=100x10^9/L (no correction within 7 days) treatment); hemoglobin >= 90 g/L (without corrective treatment within 7 days); (2) Liver and kidney function: TBIL=50 mL/min (Cockcroft-Gault formula); (3) echocardiography: left ventricular ejection fraction (LVEF) >= 50%; (4) 12-lead ECG: QT interval <= 480 ms. 6. Able to accept needle biopsy; 7. Voluntarily join the study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Receiving any other anti-tumor therapy at the same time; 2. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 3. Other malignant tumors have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and other malignant tumors; 4. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption; 5. Subjects with cardiac insufficiency, including but not limited to subjects with congestive heart failure, transmural myocardial infarction, angina pectoris requiring drug treatment, clinically significant valvular heart disease and high-risk arrhythmia or during the screening ECG examination Abnormal and clinically significant QTc (QTc>450 ms [male] or QTc>470 ms [female] after ECG correction at rest); 6. Uncontrolled hypertension (at rest: systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); 7. Subjects with evidence of severe or uncontrolled systemic diseases (such as unstable or uncompensated respiratory, cardiac, hepatic or renal diseases) according to the judgment of the investigator; 8. Pregnant or lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 9. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of patients, or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes and active infections, etc.); 10. Those who are known to be allergic to any of the active ingredients or excipients of ARX788, or have a clear history of protein drug allergy, history of specific allergic reactions (asthma, rheumatism, eczema dermatitis), or have had other severe allergic reactions that have been Those who are judged by the investigator to be unsuitable for ARX788 treatment; 11. Patients with pulmonary interstitial disease requiring hormone therapy, drug-induced pulmonary interstitial disease, history of radiation pneumonitis, or clinically active pulmonary interstitial disease suggested by any evidence; 12. Those who currently suffer from keratitis, corneal disease, retinal disease or active eye infection and other eye diseases that require eye treatment intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual tumor burden classification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best overall response rate ;Total pathological complete response rate;Total breast pathological complete remission rate;Disease-free survival ;Overall survival;Adverse events;adverse events; | — |
Countries
China
Contacts
Public ContactLiu Caigang
Shengjing Hospital of China Medical University
Outcome results
None listed