Advanced Triple-Negative Breast Cancer
Conditions
Interventions
Camrelizumab combined with pirfenidone and chemotherapy :Camrelizumab: 200 mg, administered by intravenous infusion on day 1 of each 21-day cycle.
Pirfenidone: Administered orally. Initial dose: 200
Sponsors
Harbin medical university cancer hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged >= 18 years and = 3 months. (For neoadjuvant/adjuvant therapy, if disease progression occurred during treatment or within 6 months after stopping treatment, it will be counted as one line of prior therapy). 6.Major organ function levels meeting the following criteria (no blood transfusion or use of granulocyte colony-stimulating factor (G-CSF), platelet-boosting drugs within 2 weeks prior to screening): 1)Hematological tests must meet: ANC >= 1.5×10^9 /L; PLT >= 90×10^9 /L; Hb >= 90 g/L; 2)Biochemical tests must meet the following standards: TBIL = 50 mL/min (calculated by Cockcroft-Gault formula); 3)Thyroid-stimulating hormone (TSH) = 50%; 5)12-lead ECG: QT interval corrected by Fridericia's method (QTcF) <480 ms for females; 7.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and must voluntarily use adequate methods of contraception during the observation period and for 4 months after the last dose of the study drug. 8.Voluntary participation, signed informed consent form, and good compliance.
Exclusion criteria
Exclusion criteria: 1.Concurrently receiving anti-tumor therapy in other clinical trials; 2.Received other anti-tumor treatments within 14 days prior to the first dose; 3.Previous treatment with pirfenidone; 4.Subjects with untreated active brain metastases or leptomeningeal metastases; 5.Underwent major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgery; 6.Subjects with any active autoimmune disease or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has been completely resolved and requires no intervention in adulthood may be enrolled; subjects with asthma requiring bronchodilators for medical intervention are excluded); 7.Severe cardiac diseases or conditions, including but not limited to: a documented history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or advanced atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block); angina pectoris requiring anti-anginal medication; clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg); 8.Subjects with congenital or acquired immunodeficiency (e.g., HIV infection); 9.Received live vaccines within 4 weeks prior to study treatment or potential vaccination during the study period; 10.Known history of allergy to any component of the study drugs; 11.Presence of severe concomitant diseases or other comorbid conditions that may interfere with the planned treatment, or any other situation deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Clinical benefit rate;Progression-Free Survival;Overall survival;safety; | — |
Countries
china
Contacts
Public Contactzhaowenhui;liutong
Harbin medical university cancer hospital
Outcome results
None listed