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Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01199393
First Posted: September 13, 2010
Last Update Posted: July 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital
  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:


Further study details as provided by Jun Ren, Beijing Cancer Hospital:

Primary Outcome Measures:
  • Response to chemotherapy [ Time Frame: 6 months ]
    Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).


Secondary Outcome Measures:
  • 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
about 4ml peripheral vein blood

Enrollment: 153
Study Start Date: August 2010
Study Completion Date: May 2015
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199393


Locations
China
Beijing Cancer Hospital
Beijing, China, 100142
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

Responsible Party: Jun Ren, Director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01199393     History of Changes
Other Study ID Numbers: snp
First Submitted: August 31, 2010
First Posted: September 13, 2010
Last Update Posted: July 29, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases