Metastatic Breast CancerCTC-MBCNCT01322893
Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Lund University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with metastatic breast cancer
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, Circulating tumour cells, CTC, Prognostic factors, Treatment response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling. | Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322893
- Sponsor's protocol ID
- Version2. 2011-03-03
- Acronym
- CTC-MBC
- Status last verified
- May 2019
- First submitted
- 24 Mar 2011
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36945037Narbe 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.
PubMed 32709042Larsson 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.
PubMed 29884204Jansson 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.
PubMed 27390845Frithiof 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.
PubMed 25896421
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01322893
- Acronym / sponsor ID
- CTC-MBC / Version2. 2011-03-03
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, Circulating tumour cells, CTC, Prognostic factors, Treatment response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sampling. | – | –Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with metastatic breast cancer
Key inclusion criteria (8 listed)
- Women with metastatic breast cancer
- ECOG performance status 0-2
- Age over18 years
- Signed informed concent
- Predicted life expectancy over 2 months
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Derived from this study: PubMed 36945037Gunnarsdottir 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.
- Derived from this study: PubMed 32709042Narbe 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.
- Derived from this study: PubMed 29884204Larsson 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.
- Derived from this study: PubMed 27390845Jansson 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.
- Derived from this study: PubMed 25896421Frithiof 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.
- A novel method for downstream characterization of breast cancer circulating tumor cells following CellSearch isolation. - PubMed - NCBILink provided by the sponsor.
- Prognostic impact of circulating tumor cell apoptosis and clusters in serial blood samples from patients with metastatic breast cancer in a prospec... - PubMed - NCBILink provided by the sponsor.
- A FISH-based method for assessment of HER-2 amplification status in breast cancer circulating tumor cells following CellSearch isolation. - PubMed - NCBILink provided by the sponsor.
- Evolution of Estrogen Receptor Status from Primary Tumors to Metastasis and Serially Collected Circulating Tumor Cells.Link provided by the sponsor.
- Serial evaluation of serum thymidine kinase activity is prognostic in women with newly diagnosed metastatic breast cancer.Link provided by the sponsor.
- Longitudinal CTC and CTC-cluster evaluation improves prognostication and monitoring in metastatic breast cancer patients during 1st line systemic treatment.Link provided by the sponsor.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322893, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.