Breast CancerNCT00493350
Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC). 2. To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood Sample
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.
Who may be able to join
- Patients must have histologically or cytologically confirmed invasive breast cancer. Patients must have clinical and/or radiologic evidence of stage IV disease. Tumor may be of any hormone receptor type.
- Patients must have newly diagnosed stage IV breast cancer that is scheduled to start a new systemic therapy.
- Patients may have measurable or non-measurable disease.
- Extent of disease will be determined by physical examination and imaging studies as per the primary physician. The tests utilized may include: (bone scans, PET/CT scans, CT of the abdomen, chest radiograph and/or CT of the chest for visceral metastases, sonogram and/or MRI for soft tissue disease). Patients with skin lesions will have photographs to evaluate their lesions.
- ECOG performance status 0-2.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.
Who cannot join
- Patients with evidence of local regional recurrence only are excluded.
- Patients who have received prior therapy for their metastatic breast disease.
- Patients with known evidence of brain metastases (unless previously treated or stable) or carcinomatous meningitis.
- Patients with history of any prior malignancies that have not been disease-free for at least 5 years prior to study entry.
- Patients unwilling or unable to give consent.
- Patients unwilling or unable to provided follow-up on their condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment
Primary Objectives:
- To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC).
- To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy).
- To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB.
Read more
Secondary Objective:
- To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.
Read the detailed description
Patients with tumors that have spread to other parts of the body and who are about to start systemic treatment will be eligible to take part in this study.
As is standard of care, you will have an evaluation of your disease through CT scans, bone scans, and PET scans. Before you begin your routine treatment, participants in this study will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only blood draw required for this study. You will then begin receiving standard therapy for your disease as decided by your treating physician.
You will have follow-ups with either your physician or through the research personnel (by phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months, follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your medical record will be reviewed to gather information for this study.
One of the blood samples will be preserved and used for research and development purposes specifically related to this study. This research includes also analysis of the tumor gene profiling. This study will be done to better understand the biology of metastatic breast cancer. Neither participants nor the doctors taking care of them will be told about the results of the research.
This is an investigational study. CellSearch (the technology used to count circulating tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Blood Sample
- Keywords
- Breast Cancer, Circulating Tumor Cells, Gene Profiling, International Stage Stratification Study, Blood Sample, ISSS
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleProcedure or surgery
1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy. Receives: Procedure: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer.
Measured: 26 Months
Secondary outcomes (1)
To learn if the detection of circulating cancer cells is a predictor for a worse disease prognosis.
Measured: 26 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Diagnostics, LLC
- Responsible party
- Sponsor
- Investigators
- Massimo Cristofanilli, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493350
- Sponsor's protocol ID
- 2005-0278
- Status last verified
- Jul 2012
- First submitted
- 26 Jun 2007
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment
- ClinicalTrials.gov ID
- NCT00493350
- Acronym / sponsor ID
- 2005-0278
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Circulating Tumor Cells, Gene Profiling, International Stage Stratification Study, Blood Sample, ISSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Janssen Diagnostics, LLC
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Jun 2007 (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.
Primary Objectives:
- To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC).
- To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy).
- To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB.
Secondary Objective:
- To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.
Detailed description
Patients with tumors that have spread to other parts of the body and who are about to start systemic treatment will be eligible to take part in this study.
As is standard of care, you will have an evaluation of your disease through CT scans, bone scans, and PET scans. Before you begin your routine treatment, participants in this study will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only blood draw required for this study. You will then begin receiving standard therapy for your disease as decided by your treating physician.
You will have follow-ups with either your physician or through the research personnel (by phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months, follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your medical record will be reviewed to gather information for this study.
One of the blood samples will be preserved and used for research and development purposes specifically related to this study. This research includes also analysis of the tumor gene profiling. This study will be done to better understand the biology of metastatic breast cancer. Neither participants nor the doctors taking care of them will be told about the results of the research.
This is an investigational study. CellSearch (the technology used to count circulating tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Blood SamplePatients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.
Key inclusion criteria (6 listed)
- Patients must have histologically or cytologically confirmed invasive breast cancer. Patients must have clinical and/or radiologic evidence of stage IV disease. Tumor may be of any hormone receptor type.
- Patients must have newly diagnosed stage IV breast cancer that is scheduled to start a new systemic therapy.
- Patients may have measurable or non-measurable disease.
- Extent of disease will be determined by physical examination and imaging studies as per the primary physician. The tests utilized may include: (bone scans, PET/CT scans, CT of the abdomen, chest radiograph and/or CT of the chest for visceral metastases, sonogram and/or MRI for soft tissue disease). Patients with skin lesions will have photographs to evaluate their lesions.
- ECOG performance status 0-2.
Key exclusion criteria (6 listed)
- Patients with evidence of local regional recurrence only are excluded.
- Patients who have received prior therapy for their metastatic breast disease.
- Patients with known evidence of brain metastases (unless previously treated or stable) or carcinomatous meningitis.
- Patients with history of any prior malignancies that have not been disease-free for at least 5 years prior to study entry.
- Patients unwilling or unable to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers) | Procedure or surgery | 1 |
Primary outcome
To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer.
Time frame: 26 Months
1 secondary outcome
To learn if the detection of circulating cancer cells is a predictor for a worse disease prognosis.
Time frame: 26 Months
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 31 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Massimo Cristofanilli, MD principal investigator
M.D. Anderson Cancer Center
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 Breast Cancer, run by M.D. Anderson Cancer Center 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 6 inclusion and 6 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 31 Jul 2012. 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?
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 detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer. (time frame: 26 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 31 Jul 2012.