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

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT01322893
• Lead Sponsor: Lund University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden