Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasm
- Sponsor
- Peking University Cancer Hospital & Institute
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Response to chemotherapy
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.
Detailed Description
1. Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. 2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc. 3. Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.
Investigators
Jun Ren
Director
Peking University Cancer Hospital & Institute
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed metastatic breast cancer
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •At least one measurable lesion
- •Normal cardiac, hepatic, renal and bone marrow functions
- •Life expectancy ≥3 months
- •Discontinuity of previous chemotherapy for a minimum of 4 weeks
Exclusion Criteria
- •Central nervous system metastases
- •Serious or uncontrolled concurrent medical illness
- •History of other malignancies
Outcomes
Primary Outcomes
Response to chemotherapy
Time Frame: 6 months
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
Secondary Outcomes
- Time to disease progression(1 year)
- Toxicity(6 months)
- Overall survival(5 years)