Metastatic Breast Cancer Clinical Trial
— CTC-MBCOfficial title:
Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
| NCT number | NCT01322893 |
| Other study ID # | Version2. 2011-03-03 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2011 |
| Est. completion date | June 2016 |
| Verified date | May 2019 |
| Source | Lund University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Lund University Hospital | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6. |
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