Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Recruitment status was Recruiting
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: Response to chemotherapy is evaluated every two cycles of chemotherapy. ] [ Designated as safety issue: Yes ]Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
- Time to disease progression [ Time Frame: Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression. ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Overall survival is measured from the date therapy is initiated to the date of death or final follow-up. ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: Toxicity is assessed every cycle of chemotherapy ] [ 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|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2012 (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
|Contact: Jun Ren, MDemail@example.com|
|Contact: Ningning Dong, PhDfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, China, 100142|
|Contact: Jun Ren, MD +86-10-88196356 email@example.com|
|Contact: Ningning Dong, PhD +86-10-88196328 firstname.lastname@example.org|
|Principal Investigator:||Ningning Dong, PhD||Beijing Cancer Hospital|
|Study Director:||Jun Jia, MD||Beijing Cancer Hospital|