Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer|
- Response to chemotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
- Time to disease progression [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.
- Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Toxicity, as a measure of safety and tolerability, is assessed by the percent of participants with adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC). Possible toxicities include neutropenia, anemia, thrombocytopenia, nausea and vomitting, allergy, and so on.
Biospecimen Retention: Samples With DNA
about 4ml peripheral vein blood
|Study Start Date:||August 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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.
- 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.
- Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199393
|Beijing Cancer Hospital|
|Beijing, China, 100142|
|Principal Investigator:||Ningning Dong, PhD||Beijing Cancer Hospital|
|Study Director:||Jun Jia, MD||Beijing Cancer Hospital|