Clinical trial NCT01322893: Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
Official title: Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
Circulating tumour cells
CTC
Prognostic factors
Treatment response
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with metastatic breast cancer

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
References:
citation: Narbe U, Bendahl PO, Aaltonen K, Ferno M, Forsare C, Jorgensen CLT, Larsson AM, Ryden L. The Distribution of Circulating Tumor Cells Is Different in Metastatic Lobular Compared to Ductal Carcinoma of the Breast-Long-Term Prognostic Significance. Cells. 2020 Jul 17;9(7):1718. doi: 10.3390/cells9071718.
citation: Larsson AM, Jansson S, Bendahl PO, Levin Tykjaer Jorgensen C, Loman N, Graffman C, Lundgren L, Aaltonen K, Ryden L. Longitudinal enumeration and cluster evaluation of circulating tumor cells improve prognostication for patients with newly diagnosed metastatic breast cancer in a prospective observational trial. Breast Cancer Res. 2018 Jun 8;20(1):48. doi: 10.1186/s13058-018-0976-0.
citation: Jansson S, Bendahl PO, Larsson AM, Aaltonen KE, Ryden L. Prognostic impact of circulating tumor cell apoptosis and clusters in serial blood samples from patients with metastatic breast cancer in a prospective observational cohort. BMC Cancer. 2016 Jul 8;16:433. doi: 10.1186/s12885-016-2406-y.
citation: Frithiof H, Welinder C, Larsson AM, Ryden L, Aaltonen K. A novel method for downstream characterization of breast cancer circulating tumor cells following CellSearch isolation. J Transl Med. 2015 Apr 21;13:126. doi: 10.1186/s12967-015-0493-1.