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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01322893
Acronym
CTC-MBC
Enrollment
150
Registered
2011-03-25
Start date
2011-03-31
Completion date
2016-06-30
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer, Circulating tumour cells, CTC, Prognostic factors, Treatment response

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.

Interventions

None listed

Sponsors

Lund University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 treatmentBlood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026