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Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

This study is currently recruiting participants.
Verified August 2010 by Beijing Cancer Hospital
Sponsor:
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01199393
First received: August 31, 2010
Last updated: September 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition
Breast Neoplasm
Drug Therapy
Polymorphism,Single Nucleotide

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
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)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

female patients with metastatic breast cancer

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199393

Contacts
Contact: Jun Ren, MD +86-10-88196356 renjun9688@yahoo.com
Contact: Ningning Dong, PhD +86-10-88196328 dongnn83@163.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Jun Ren, MD     +86-10-88196356     renjun9688@yahoo.com    
Contact: Ningning Dong, PhD     +86-10-88196328     dongnn83@163.com    
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Principal Investigator: Ningning Dong, PhD Beijing Cancer Hospital
Study Director: Jun Jia, MD Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Jun Ren/Director of the Medical Oncology Department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01199393     History of Changes
Other Study ID Numbers: snp
Study First Received: August 31, 2010
Last Updated: September 10, 2010
Health Authority: China: Ministry of Health

Keywords provided by Beijing Cancer Hospital:
breast neoplasm
drug therapy
polymorphism
gene

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
 Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013