Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Completed

• Conditions: Breast Neoplasm; Drug Therapy; Polymorphism,Single Nucleotide

• Registration Number: NCT01199393
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

• Histologically confirmed metastatic breast cancer
• Female
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to chemotherapy	6 months	Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	1 year	Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
Toxicity	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.
Overall survival	5 years	Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China