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Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

18 Years
75 Years
Open (Enrolling)
Breast Neoplasm, Drug Therapy, Polymorphism,Single Nucleotide

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Trial Information

Genetic Polymorphisms 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,

3. Statistical Analysis x2 test is used to summarize the association of response and
adverse events to chemotherapy with genetic polymorphisms.

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Response to chemotherapy

Outcome Description:

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

Outcome Time Frame:

Response to chemotherapy is evaluated every two cycles of chemotherapy.

Safety Issue:


Principal Investigator

Ningning Dong, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital


China: Ministry of Health

Study ID:




Start Date:

August 2010

Completion Date:

July 2013

Related Keywords:

  • Breast Neoplasm
  • Drug Therapy
  • Polymorphism,Single Nucleotide
  • breast neoplasm
  • drug therapy
  • polymorphism
  • gene
  • Breast Neoplasms
  • Neoplasms