NCT01322893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2019

Enrollment Period

5.3 years

First QC Date

March 24, 2011

Last Update Submit

May 20, 2020

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancerCirculating tumour cellsCTCPrognostic factorsTreatment response

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Blood sampling.

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with metastatic breast cancer

You may qualify if:

  • 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)
  • Planned for standard imaging within 16 weeks after start of therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

Location

Related Publications (5)

  • Gunnarsdottir 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: 36945037DERIVED

  • 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.

    PMID: 32709042DERIVED

  • 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.

    PMID: 29884204DERIVED

  • 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.

    PMID: 27390845DERIVED

  • 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.

    PMID: 25896421DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 22, 2020

Record last verified: 2019-05

Locations

SE(1)