Metastatic Breast Cancer (MBC)CTC-EXPRESSNCT06833853
A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients
An observational study of Metastatic Breast Cancer (MBC), run by Menarini Silicon Biosystems, INC at 1 site in United States.
Trial summary
The purpose of this research is to learn if the CellSearch Circulating Tumor Cells (CTC) test can help doctors in making decisions about treatment and monitoring of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer (MBC)
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2026to Oct 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in metastatic setting: * Estrogen Receptor (ER)+/Human Epidermal growth factor Receptor 2 (HER2) - or Triple Negative (TN) patients prior to starting any line of systemic therapy * HER2+ patients prior to starting 2nd line or later therapy
Who may be able to join
- Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease.
- HR+/HER2 negative or triple negative (TN) subjects prior to starting first line therapy or beyond in the metastatic setting.
- OR HER2+ subjects prior to starting second line therapy or beyond in the metastatic setting.
- Subject must have the CTC HER2, ER, PD-L1, and cfDNA/RNA tests ordered during routine patient care.
- Age > 18 years.
Who cannot join
- Participant is pregnant.
- Inability to provide blood samples based on the judgment of the treating physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisette Stork-Sloots contact
United States1 site, 1 recruiting
- Recruiting
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Marija Balic, MD, PhD, MBA
About this study
Official title: CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer
The purpose of this research is to learn if the CellSearch Circulating Tumor Cells (CTC) test can help doctors in making decisions about treatment and monitoring of breast cancer. The test consists of diagnostic CTC counts (enumeration) and expression of biomarkers Human Epidermal growth factor Receptor 2 (HER2), Estrogen Receptor (ER), and programmed death-ligand 1 (PD-L1) and cell free DNA/RNA (cfDNA/RNA) analysis.
Read the detailed description
A prospective, multicenter, observational study of CellSearch CTC enumeration, CTC HER2, ER, and PD-L1 expression, and MSearch cfDNA/RNA results in subjects with histologically proven MBC. Treatment for MBC will be chosen and performed by treating physicians/providers. Eligible subjects will be enrolled after signing the ICF. Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of Standard of Care (SoC). Subjects will receive any additional cfDNA/RNA assessments as part of research collection. For all subjects 4 to 6 tubes will be collected at baseline and minimally before the first restaging visit. For any subsequent restaging visits a total of 3 to 4 tubes will be collected.
- Conditions
- Metastatic Breast Cancer (MBC)
- Keywords
- CTC, cfDNA, cfRNA
- 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 |
|---|---|---|
| HR+/HER2- subjects before starting 1st line therapy | Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of standard of care. Subjects will have additional cfDNA/RNA tests at week 4, and 8. | |
| Triple negative starting any line of therapy, HR+/HER2-, and HER2+ starting ≥2nd line therapy | Subjects will receive CTC enumeration, and CTC HER2, ER, PD-L1 expression minimally before each restaging visit, and cfDNA/RNA assessments at baseline and first restaging as part of standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.
The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA/RNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA/RNA results in subjects with MBC.
Measured: 3-4 months
Secondary outcomes (6)
The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1.
Measured: 1 month
The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1.
Measured: 3-4 months
The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS).
Measured: 24 months
The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS.
Measured: 24 months
The correlation of early cfDNA/RNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +/HER2- MBC.
Measured: 24 months
The correlation of CTC enumeration results with PFS.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start13 Mar 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer (MBC)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Menarini Silicon Biosystems, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marija Balic, MD, PhD, MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833853
- Sponsor's protocol ID
- CTC-EXPRESS
- Acronym
- CTC-EXPRESS
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06833853
- Acronym / sponsor ID
- CTC-EXPRESS / CTC-EXPRESS
- Conditions
- Metastatic Breast Cancer (MBC)
- Keywords
- CTC, cfDNA, cfRNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Menarini Silicon Biosystems, INCIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 19 Feb 2025 (actual)
- 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.
The purpose of this research is to learn if the CellSearch Circulating Tumor Cells (CTC) test can help doctors in making decisions about treatment and monitoring of breast cancer. The test consists of diagnostic CTC counts (enumeration) and expression of biomarkers Human Epidermal growth factor Receptor 2 (HER2), Estrogen Receptor (ER), and programmed death-ligand 1 (PD-L1) and cell free DNA/RNA (cfDNA/RNA) analysis.
Detailed description
A prospective, multicenter, observational study of CellSearch CTC enumeration, CTC HER2, ER, and PD-L1 expression, and MSearch cfDNA/RNA results in subjects with histologically proven MBC. Treatment for MBC will be chosen and performed by treating physicians/providers. Eligible subjects will be enrolled after signing the ICF. Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of Standard of Care (SoC). Subjects will receive any additional cfDNA/RNA assessments as part of research collection. For all subjects 4 to 6 tubes will be collected at baseline and minimally before the first restaging visit. For any subsequent restaging visits a total of 3 to 4 tubes will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HR+/HER2- subjects before starting 1st line therapy | – | –Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of standard of care. Subjects will have additional cfDNA/RNA tests at week 4, and 8. |
| Triple negative starting any line of therapy, HR+/HER2-, and HER2+ starting ≥2nd line therapy | – | –Subjects will receive CTC enumeration, and CTC HER2, ER, PD-L1 expression minimally before each restaging visit, and cfDNA/RNA assessments at baseline and first restaging as part of standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in metastatic setting: * Estrogen Receptor (ER)+/Human Epidermal growth factor Receptor 2 (HER2) - or Triple Negative (TN) patients prior to starting any line of systemic therapy * HER2+ patients prior to starting 2nd line or later therapy
Key inclusion criteria (5 listed)
- Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease.
- HR+/HER2 negative or triple negative (TN) subjects prior to starting first line therapy or beyond in the metastatic setting.
- OR HER2+ subjects prior to starting second line therapy or beyond in the metastatic setting.
- Subject must have the CTC HER2, ER, PD-L1, and cfDNA/RNA tests ordered during routine patient care.
- Age > 18 years.
Key exclusion criteria (2 listed)
- Participant is pregnant.
- Inability to provide blood samples based on the judgment of the treating physician.
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
The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.
Time frame: 3-4 months
The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA/RNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA/RNA results in subjects with MBC.
6 secondary outcomes
The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1.
Time frame: 1 month
The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1.
Time frame: 3-4 months
The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS).
Time frame: 24 months
The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS.
Time frame: 24 months
The correlation of early cfDNA/RNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +/HER2- MBC.
Time frame: 24 months
The correlation of CTC enumeration results with PFS.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Breast Cancer (MBC)
Not yet recruitingPhase 3
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease
Metastatic Breast Cancer in the Liver
RecruitingObservational study
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma
RecruitingObservational study
Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
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.
Lisette Stork-Sloots contact
Marija Balic, MD, PhD, MBA principal investigator
University of Pittsburgh
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 (MBC), run by Menarini Silicon Biosystems, INC at 1 site in United States.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marija Balic, MD, PhD, MBA (800-533-8762, balicm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results. (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.