Metastatic Breast CancerNCT01116869
China CellSearch Study
An observational study of Metastatic Breast Cancer and Benign Breast Disease, run by Johnson & Johnson Medical, China at 1 site in China.
Trial summary
The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Breast Cancer, Benign Breast Disease
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2010to 6 Jan 2014
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The hazard ratio of disease progression in patients with unfavorable versus favorable CTC counts at baseline, 3-4 weeks and 6-8 weeks after the initiation of therapy will be estimated using Cox regression. Kaplan-Meier plots for PFS will be constructed using the favorable and unfavorable CTC patient groups. The log-rank test will be used to determine if the curves for the two CTC groups are statistically significantly different. The hazard ratio of death in patients with unfavorable versus favorable CTC counts at each blood draw time point will be estimated using Cox regression. Kaplan-Meier plots for OS will be constructed using the favorable and unfavorable CTC patient groups.
Who may be able to join
- Female
- over 18 and less than 70 years of age
- Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.
- For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline Starting a new line of systemic therapy which is recommended in the Chinese edition of NCCN Clinical Practice Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy should be over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months
- For Healthy Subject Set only Medical examinations detect no breast benign and malignant tumors
- For Benign Breast Disease Subject Set only Pathology diagnosed breast benign tumor disease
Who cannot join
- Self reported pregnancy
- For MBC Subject Set only Prior history of other malignancy Patients who have surgery to remove any metastatic lesions or receive radiation therapy during her participation in the study
- For Healthy Subject Set only Prior history of breast benign tumor disease or any malignancy Any conditions inappropriate for blood drawing
- For Benign Breast Disease Subject Set only Prior history of any malignancy Any conditions inappropriate for blood drawing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Prospective Study to Evaluate the Ability of CTC Enumeration Using the CellSearch® Circulating Tumor Cell Kit to Predict Prognosis and to Assess the Agreement Between CTC and Imaging Determined Response in MBC Patients 一项评价CellSearch® 循环肿瘤细胞检测试剂盒对复发转移性乳腺癌患者进行循环肿瘤细胞检测 以预测病人预后的能力及循环肿瘤细胞检测和影像学疗效判断之间一致性的多中心、前瞻性的研究
The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China.
The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.
The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
Read the detailed description
A longitudinal, multi-center, prospective study will be conducted in MBC patients to evaluate the ability of CTC to predict the patients' prognosis. A separate population of healthy and benign disease subjects will serve as controls to compare the CTC incidence in this control group versus the MBC group at baseline. Correlation between CTC and radiographic response to the systemic therapies in the MBC study group will also be assessed.
300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival.
200 healthy and benign disease volunteers, each of whom will donate blood 1 time for CTC analysis, will be enrolled as controls.
- Conditions
- Metastatic Breast Cancer, Benign Breast Disease
- Keywords
- MBC, Healthy, Benign disease, Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline, Medical examinations detect no breast benign and malignant tumors, Benign Breast Disease, Pathology diagnosed breast benign tumor disease
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis, 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 |
|---|---|---|
| MBC patients | 300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival. | |
| Benign disease volunteers | 100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls. | |
| Healthy volunteers | 100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.
Measured: 12 months
Secondary outcomes (2)
Ability of CTC levels to predict overall survival (OS) in MBC patients.
Measured: 3 years
Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patient's response as determined by imaging evaluation (6-8 weeks after the initiation of therapy) in MBC patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start25 Mar 2010
- Primary completion22 Jun 2011
- Study completion6 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, Doctor, Study chair, 307 Hosptial of PLAZhimin Shao, Doctor, Principal investigator, Shanghai Cancer HosptialTao Ouyang, Doctor, Principal investigator, Beijing Cancer HosptialErwei Song, Doctor, Principal investigator, Zhongshan 2nd HospitalNing Liao, Doctor, Principal investigator, The Second People's Hospital of GuangDong ProvinceXiaojia Wang, Doctor, Principal investigator, Zhejiang Cancer HosptialZhongsheng Tong, Doctor, Principal investigator, Tianjin Cancer Hospital Airport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116869
- Sponsor's protocol ID
- 200901
- Status last verified
- Nov 2019
- First submitted
- 4 May 2010
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Study to Evaluate the Ability of CTC Enumeration Using the CellSearch® Circulating Tumor Cell Kit to Predict Prognosis and to Assess the Agreement Between CTC and Imaging Determined Response in MBC Patients 一项评价CellSearch® 循环肿瘤细胞检测试剂盒对复发转移性乳腺癌患者进行循环肿瘤细胞检测 以预测病人预后的能力及循环肿瘤细胞检测和影像学疗效判断之间一致性的多中心、前瞻性的研究
- ClinicalTrials.gov ID
- NCT01116869
- Acronym / sponsor ID
- 200901
- Conditions
- Metastatic Breast Cancer, Benign Breast Disease
- Keywords
- MBC, Healthy, Benign disease, Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline, Medical examinations detect no breast benign and malignant tumors, Benign Breast Disease, Pathology diagnosed breast benign tumor disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2010 (actual)
- Primary completion
- 22 Jun 2011 (actual)
- Study completion
- 6 Jan 2014 (actual)
- First posted
- 5 May 2010 (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.
The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China.
The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.
The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
Detailed description
A longitudinal, multi-center, prospective study will be conducted in MBC patients to evaluate the ability of CTC to predict the patients' prognosis. A separate population of healthy and benign disease subjects will serve as controls to compare the CTC incidence in this control group versus the MBC group at baseline. Correlation between CTC and radiographic response to the systemic therapies in the MBC study group will also be assessed.
300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival.
200 healthy and benign disease volunteers, each of whom will donate blood 1 time for CTC analysis, will be enrolled as controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBC patients | – | –300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival. |
| Benign disease volunteers | – | –100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls. |
| Healthy volunteers | – | –100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The hazard ratio of disease progression in patients with unfavorable versus favorable CTC counts at baseline, 3-4 weeks and 6-8 weeks after the initiation of therapy will be estimated using Cox regression. Kaplan-Meier plots for PFS will be constructed using the favorable and unfavorable CTC patient groups. The log-rank test will be used to determine if the curves for the two CTC groups are statistically significantly different. The hazard ratio of death in patients with unfavorable versus favorable CTC counts at each blood draw time point will be estimated using Cox regression. Kaplan-Meier plots for OS will be constructed using the favorable and unfavorable CTC patient groups.
Key inclusion criteria (6 listed)
- Female
- over 18 and less than 70 years of age
- Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.
- For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline Starting a new line of systemic therapy which is recommended in the Chinese edition of NCCN Clinical Practice Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy should be over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months
- For Healthy Subject Set only Medical examinations detect no breast benign and malignant tumors
Key exclusion criteria (4 listed)
- Self reported pregnancy
- For MBC Subject Set only Prior history of other malignancy Patients who have surgery to remove any metastatic lesions or receive radiation therapy during her participation in the study
- For Healthy Subject Set only Prior history of breast benign tumor disease or any malignancy Any conditions inappropriate for blood drawing
- For Benign Breast Disease Subject Set only Prior history of any malignancy Any conditions inappropriate for blood drawing
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
Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.
Time frame: 12 months
2 secondary outcomes
Ability of CTC levels to predict overall survival (OS) in MBC patients.
Time frame: 3 years
Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patient's response as determined by imaging evaluation (6-8 weeks after the initiation of therapy) in MBC patients.
Time frame: 12 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 15 Nov 2019.
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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.
Zefei Jiang, Doctor study chair
307 Hosptial of PLA
Zhimin Shao, Doctor principal investigator
Shanghai Cancer Hosptial
Tao Ouyang, Doctor principal investigator
Beijing Cancer Hosptial
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 and Benign Breast Disease, run by Johnson & Johnson Medical, China at 1 site in China.
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 4 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 15 Nov 2019. 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 China. 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?
Ability of CTC levels to predict progression-free survival (PFS) in MBC patients. (time frame: 12 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 15 Nov 2019.