Breast Cancer
Conditions
Interventions
1:Irinotecan
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years patients with metastatic breast cancer previously. 2. Female patients with histologically or cytologically confirmed locally recurrent or metastatic breast cancer. 3. Estrogen and progesterone receptor testing criteria are based on the guideline for immunohistochemical testing of estrogen and progesterone receptors in breast cancer jointly developed by ASCO and CAP in 2010. 4. Patients with locally recurrent or metastatic breast cancer who have been treated with at least 2 chemotherapy regimens: ? The regimens must include any anthracycline (e.g., doxorubicin, epirubicin) and any taxane (e.g., paclitaxel, docetaxel) in any combination; ? Disease progression must have occurred during the last chemotherapy or <6 months after the last chemotherapy. Patients with HER2/ neu-positive breast cancer must have either taken HER2/ neu-targeted drugs (e.g.,an antibody or small-molecule drug) or have forgone anti-HER2 therapy because of the inability to afford this treatment. Patients with estrogen receptor-positive tumors have received endocrine therapy. 5. Measurable lesions (based on computed tomography or magnetic resonance imaging) that have a longest diameter of =10 mm based on the RECIST v1.1 and a shortest lymph node diameter of =15 mm. 6. Eastern Cooperative Oncology Group performance status score 0–2. 7. Life expectancy of =12 weeks. 8. Adequate bone marrow capacity, hepatic functional reserve, and renal functional reserve within 7 days before screening: Absolute neutrophils count 1.5×10^9/L; Hemoglobin =9.0 g/dL; Platelet count =80 × 10^9/L; Total bilirubin <1.5 times the ULN; Aspartate and alanine transaminases =2.5 times the ULN (=5 times the ULN for liver metastases); Alkaline phosphatase <4 times the ULN; Serum creatinine =1.5 times the ULN. 9. Women of childbearing age requiring effective contraception. 10. Provision of informed consent.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, radiotherapy, HER2/neu-targeting drugs (including trastuzumab), or hormonal therapy within the past 3 weeks. 2. Breast cancer patients who did not receive local treatment and developed brain and dural metastasis. However, patients will be eligible if corticosteroids for brain and dural metastasis have been withdrawn for at least 4 weeks, if the signs and/or symptoms of brain metastasis have been stable for =4 weeks, and if imaging findings confirm that the disease is stable over the 4 weeks preceding the date of screening. 3. Severe cardiovascular injury (congestive heart failure of class II or worse based on the New York Heart Association classification), unstable angina, myocardial infarction, or severe arrhythmia during the past 6 months. 4. A history of human immunodeficiency virus infection, chronic hepatitis B, or hepatitis C (high viral DNA copy) at the active phase. 5. Clinical evidence of other severe active infection. 6. Patients with homozygous mutations in UGT1A1*6 and/or UGT1A1*28 (such patients are susceptible to irinotecan-induced diarrhea). 7. Patients with allogeneic organ transplants that require immunosuppressive therapy. 8. A history of other malignancies within 5 years, except for cured cervical carcinoma in situ or basal cell skin cancer. Women who are pregnant, lactating, or of childbearing age but not using adequate contraception. 9. Drug abuse and medical, psychological, or social conditions that could interfere with the patients ability to consent or that might affect the studys results. 10. Known or suspected allergy to the primary agent or any other drug administered during the study. 11. Any unstable condition that might jeopardize the patients safety and compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ????; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS);Overall survival;The incidences of grade 3–4 AEs; | — |
Countries
China
Contacts
Public ContactTao Sun
Liaoning Cancer Hospital & Institute
Outcome results
None listed