Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

N/ACompletedNCT01199393

Peking University Cancer Hospital & Institute153 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

153

Conditions

Breast Neoplasm Drug Therapy Polymorphism,Single Nucleotide

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Cancer Hospital

Beijing, China

Outcomes

Primary Outcomes

Response to chemotherapy

Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

Time frame: 6 months

Secondary Outcomes

Time to disease progression

Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.

Time frame: 1 year

Overall survival

Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.

Time frame: 5 years

Toxicity

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.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.