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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood sampling.

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No