Skip to main content
OpenTrials
Completed

NCT Number: NCT01199393

Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Drug Therapy Neoplasms Neoplasms by Site Polymorphism,Single Nucleotide Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, 100142, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response to chemotherapy

    Time frame: 6 months

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 13, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.