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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lund University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Acronym: CTC-MBC

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Mar 25, 2011
Registry last updated: May 22, 2020

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.

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

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