Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Breast Neoplasm Clinical Trial

Official title:

Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199393
• Other study ID #: snp
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: July 27, 2015
• Start date: August 2010
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Drug Therapy
• Polymorphism,Single Nucleotide

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to chemotherapy	Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).	6 months	Yes
Secondary	Time to disease progression	Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.	1 year	Yes
Secondary	Overall survival	Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.	5 years	Yes
Secondary	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.	6 months	Yes