Clinical trial · Observational
Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
NCT01322893CI-TRIAL-00045226CTC-MBCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Blood sampling.
- description
- Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- DERIVEDGunnarsdottir FB, Bendahl PO, Johansson A, Benfeitas R, Ryden L, Bergenfelz C, Larsson AM. Serum immuno-oncology markers carry independent prognostic information in patients with newly diagnosed metastatic breast cancer, from a prospective observational study. Breast Cancer Res. 2023 Mar 21;25(1):29. doi: 10.1186/s13058-023-01631-6. PMID 36945037
- DERIVEDNarbe 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. PMID 32709042
- DERIVEDLarsson 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. PMID 29884204
- DERIVEDJansson 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. PMID 27390845
- DERIVEDFrithiof 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. PMID 25896421