Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01199393|
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : July 29, 2015
|Condition or disease|
|Breast Neoplasm Drug Therapy Polymorphism,Single Nucleotide|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||153 participants|
|Official Title:||Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2015|
- Response to chemotherapy [ Time Frame: 6 months ]Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
- Time to disease progression [ Time Frame: 1 year ]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 ]Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.
- Toxicity [ Time Frame: 6 months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199393
|Beijing Cancer Hospital|
|Beijing, China, 100142|
|Principal Investigator:||Ningning Dong, PhD||Beijing Cancer Hospital|
|Study Director:||Jun Jia, MD||Beijing Cancer Hospital|