This trial is active, not recruiting.

Condition metastatic breast cancer
Sponsor Lund University Hospital
Start date March 2011
End date June 2017
Trial size 150 participants
Trial identifier NCT01322893, Version2. 2011-03-03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

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

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.

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Lund University Hospital.