Breast CancerNCT00898014
Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer
An observational study of Breast Cancer, run by Institut Curie at 1 site in France.
Trial summary
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fluorescence in situ hybridization, immunologic technique and laboratory biomarker analysis
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Apr 2010
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of stage IV breast cancer
- Measurable or evaluable disease
- Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status
- Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH
PATIENT CHARACTERISTICS:
- Life expectancy > 3 months
- No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix
- No geographic, social, or psychiatric reasons that would make treatment impossible
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Predict the overall and progression-free survival of patients with stage IV breast cancer by measuring the rate of circulating tumor cells (CTC) before the second course of chemotherapy.
Secondary
- Predict overall and progression-free survival of these patients by measuring the rate of CTC before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy.
- Correlate the detection of CTC with tumor markers, clinical response, and radiological response.
- Study the changing status of HER-2 in CTC in patients receiving trastuzmab (Herceptin®).
OUTLINE: This is a multicenter study.
Blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated). Circulating tumor cells from the blood samples are examined by immunofluorescence.
Patients are followed periodically for up to 3 months.
- Conditions
- Breast Cancer
- Being tested
- fluorescence in situ hybridization, immunologic technique, laboratory biomarker analysis
- Keywords
- stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
immunologic techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of circulating tumor cells (CTC) with overall survival
Correlation of CTC with progression-free survival
Secondary outcomes (2)
Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
Change in HER-2 status in patients receiving trastuzumab (Herceptin®)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2007
- Primary completionApr 2010
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.
- 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
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Yves Pierga, MD, PhD, Study chair, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898014
- Sponsor's protocol ID
- CDR0000574195
- Other IDs
- CLCC-IC-2006-04, INCA-RECF0474
- Status last verified
- Jul 2009
- First submitted
- 9 May 2009
- Last updated
- 13 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00898014
- Acronym / sponsor ID
- CDR0000574195
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2010 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.
Detailed description
OBJECTIVES:
Primary
- Predict the overall and progression-free survival of patients with stage IV breast cancer by measuring the rate of circulating tumor cells (CTC) before the second course of chemotherapy.
Secondary
- Predict overall and progression-free survival of these patients by measuring the rate of CTC before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy.
- Correlate the detection of CTC with tumor markers, clinical response, and radiological response.
- Study the changing status of HER-2 in CTC in patients receiving trastuzmab (Herceptin®).
OUTLINE: This is a multicenter study.
Blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated). Circulating tumor cells from the blood samples are examined by immunofluorescence.
Patients are followed periodically for up to 3 months.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| fluorescence in situ hybridization | Genetic | – |
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Correlation of circulating tumor cells (CTC) with overall survival
Correlation of CTC with progression-free survival
2 secondary outcomes
Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
Change in HER-2 status in patients receiving trastuzumab (Herceptin®)
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 13 May 2011.
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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.
Jean-Yves Pierga, MD, PhD study chair
Institut Curie
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 Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2011. 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 France. 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?
Correlation of circulating tumor cells (CTC) with overall survival. The study lists 2 primary outcomes in all. 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 13 May 2011.