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


N/A
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Sweden: Regional Ethical Review Board

Study ID:

Version2. 2011-03-03

NCT ID:

NCT01322893

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic breast cancer
  • Circulating tumour cells
  • CTC
  • Prognostic factors
  • Treatment response
  • Breast Neoplasms
  • Neoplastic Cells, Circulating

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