Advanced Triple-negative Breast Cancer
Conditions
Interventions
Experimental group: Pegylated liposomal doxorubicinin and Sintilimab plus Anlotinib
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged from 18 to 70 years old. 2. Histopathologically confirmed locally advanced breast cancer (not amenable to radical local treatment) or recurrent metastatic triple-negative breast cancer; ER-negative defined as IHC <10%, PR-negative defined as IHC<10%, HER2-negative defined as IHC0/1+, or IHC2+ and ISH-negative. 3. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1. 4. Have received at least one line of chemotherapy or ADC treatment for recurrent or metastatic disease. (Neo)adjuvant therapy for early-stage disease could be considered a front-line chemotherapy if the disease recurs within 12 month. 5. Previous treatment with taxanes (paclitaxel, nab-paclitaxel, docetaxel or paclitaxel liposome. 6. Relapse occurred no less than 12 months after the last dose of an anthracycline-containing neoadjuvant or adjuvant chemotherapy regimen. 7. Have at least one measurable disease according to RECIST 1.1. 8. The main organs function levels meet the following requirements: 1) Blood routine: Hemoglobin=90g/L (No blood transfusion within 14 days); ANC =1.5×109/L; PLT =75×109/L; 2) Blood biochemistry: TBIL =1.5×ULN; ALT and AST =2.5×ULN (AST and ALT=5×ULN for patients with liver metastases); Serum creatinine =1.5×ULN and Ccr =50ml/min {Calculated by the Cockroft-Gault formula: Female Ccr(ml/min)=Male Ccr×0.85}; 3) LVEF=50%; 9. Female patients who are premenopausal or have not undergone surgical sterilization agreed to abstain from sex or use an effective contraceptive method during the treatment and for at least 6 months after the last dose. 10. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous =grade 2 hand-foot syndrome according to CTCAE V5.0. 2. Patients have one of the following conditions in the previous anti-tumor treatments: a) Patients received PD-1/PD-L1/TKI anti-angiogenic therapy; b) Previously received neoadjuvant/adjuvant treatment with doxorubicin or epirubicin treatment, and the total cumulative dose of doxorubicin is more than 350 mg/m^2 (1 mg doxorubicin is equivalent to 2 mg epirubicin); c) Previously received anthracycline for recurrent or metastatic disease; d) Has received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drugs. 3. Have multiple factors that can affect the oral administration and absorption of drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.). 4. In the past and present, participants with severe cardiac disease or discomfort , including but not limited: a) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); b) Angina pectoris requiring anti-angina medication; c) Severe, uncontrolled arrhythmias requiring medical treatment; d) Clinically significant valvular heart disease; e) ECG showing transmural myocardial infarction; f) Congestive heart failure; g) New York Heart Association grade = II. 5. Patients experienced more than one thrombotic disease event, such as cerebrovascular events (including transient cerebral ischemia), deep vein thrombosis, and pulmonary embolism, within a 6-month period. 6. Brain metastases that were active or symptomatic or required treatment were present. 7. Previously diagnosed any malignancies or presently diagnosed other malignancies except for breast cancer. 8. Have serious and/or uncontrolled diseases or medical conditions: a) History of serious neurological disorders or psychiatric disorders, including psychosis, dementia or epilepsy, which can prevent understanding and signing informed consent; b) Uncontrollable systemic disease (such as advanced infection, uncontrollable hypertension, diabetes, etc); c) Active hepatitis B and C infection; d) Have history of HIV infection; e) Have active autoimmune disease requiring systemic therapy (disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years; f) The subject has history of immunodeficiency (including congenital or acquired immunodeficiency, or history of organ transplant), or being treated with systemic steroids (prednisone 10 mg or more per day or equivalent); Have a history of immunodeficiency (including acquired or congenital immunodeficiency or organ transplantation) or current treatment with systemic steroids (prednisone at a dose of more than 10mg per day or equivalent); g) Have a history of (noninfectious) pneumonia requiring steroid treatment or current pneumonia. 9. Participants who are known to be allergic to the active or other components of the study treatment. 10. Participants who were judged by the investigator to be unsuitable for this
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress-free survival (PFS);Disease control rate (DCR);Clinical benefit rate (CBR);Overall survival (OS);Frequency and severity of adverse events;Duration of response (DOR); | — |
Countries
China
Contacts
Public ContactChunfang Hao
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed