Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer

Lund University Hospital1 site in 1 country150 target enrollmentMarch 2011

ConditionsMetastatic Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Breast Cancer
Sponsor: Lund University Hospital
Enrollment: 150
Locations: 1
Primary Endpoint: To determine whether numbers of circulating tumour cells in peripheral blood can give information of prognosis, and to evaluate if the numbers of circulating tumour cells can give information of the efficacy of given treatment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

June 2016

Last Updated

5 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Lund University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women with metastatic breast cancer
•ECOG performance status 0-2
•Age over18 years
•Signed informed concent
•Predicted life expectancy over 2 months
•Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)
•Standard imaging evaluation within 4 weeks of inclusion
•Planned for standard imaging within 16 weeks after start of therapy

Exclusion Criteria

•Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)
•Inability to understand information about the study
•Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix

Outcomes

Primary Outcomes

To determine whether numbers of circulating tumour cells in peripheral blood can give information of prognosis, and to evaluate if the numbers of circulating tumour cells can give information of the efficacy of given treatment

Time Frame: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.