locally recurrent or metastatic Her-2 negative breast cancer
Conditions
Interventions
Experimental group:irinotecan + ketogenic diet
Control group:irinotecan + normal diet
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients with histologically or cytologically confirmed locally recurrent or metastatic breast cancer. HER2 testing criteria are based on 2006 American Society of Clinical Oncology (ASCO)/American College of Pathologists (CAP)-approved HER2 testing guideline for breast cancer; 2. Aged 18–70 years; 3. Body mass index >=24 kg/m2, or body fat percentage >=28%; 4. TOP1 expression rate >=10%; 5. Patients with locally recurrent or metastatic breast cancer who are unable to receive a radical surgery and have been treated with at least two chemotherapy regimens 6. Estimated overall survival >=3 months; 7. Measurable lesions defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 2 weeks before enrollment; 8. Eastern Cooperative Oncology Group (ECOG) performance status score 0–2; 9. Provision of informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with homozygous mutations in UGT1A1*6 and/or UGT1A1*28 (such patients are susceptible to irinotecan-induced diarrhea); 2. Patients who have received chemotherapy, surgery (such as a large surgery for breast cancer) or molecular targeted therapy within 4 weeks prior to randomization or who have received hormone therapy or radiotherapy within 2 weeks prior to randomization; 3. Patients who have participated other clinical trials within 4 weeks prior to randomization; 4. Uncontrolled hypertensionor unstable angina; 5. Patients who have developed central nervous system (CNS) diseased; 6. Uncontrollable bone metastasis; 7. Known or suspected allergy to the primary agent or any other drug administered during the study; 8. A history of another primary malignancies, except for bilateral breast cancer, in situ cervical carcinoma, fully treated non-melanoma skin cancer, and malignant tumors that have been treated and have not relapsed within 5 years. 9. Lactating women; 10. Patients who are unable to cooperate with ketogenic diet if they have trouble in eating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rates (ORR);Sensitivity to irinotecan; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;progression-free survival;Overall survival;The incidences of grade 3-4 AEs; | — |
Countries
China
Contacts
Public ContactTao Sun
Liaoning Cancer Hospital & Institute
Outcome results
None listed