Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer (CTC-MBC)

Lund University Hospital

Status: Completed

Conditions: Metastatic Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01322893

Version2. 2011-03-03

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Blood sampling.

Description:

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