Breast NeoplasmsNCT01198301
Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
An observational study of Breast Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Jul 2012
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy
Who may be able to join
- Patients should be histologically confirmed with metastatic breast cancer;
- Patients who had completed the planned chemotherapy regimen with no major protocol violation;
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- At least one measurable lesion;
- Normal cardiac, hepatic, renal and bone marrow functions;
- Life expectancy ≥3 months;
- Discontinuity of previous chemotherapy for a minimum of 4 weeks.
Who cannot join
- previous history of other malignancies;
- previous surgery history on the needle biopsy organ;
- Central nervous system metastases;
- Serious or uncontrolled concurrent medical illness.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.
Read the detailed description
- Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.
- After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours.
- The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups
- Statistical analysis is performed using unsupervised hierarchical cluster.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- Metastatic Breast Neoplasms, Gene Expression Profiling, Drug Therapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy response
Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines
Measured: four-months
Secondary outcomes (3)
Time to disease progression
Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
Measured: six months
Overall survival
Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.
Measured: one year
clinical benefit response
clinical benefit response include CR,PR,SD
Measured: six months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren, Peking University Cancer Hospital & Institute
- Investigators
- Zheng Wang, PhD, Principal investigator, Peking University Cancer Hospital & InstituteJun Ren, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198301
- Sponsor's protocol ID
- GEP
- Status last verified
- Jul 2015
- First submitted
- 9 Sep 2010
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
- ClinicalTrials.gov ID
- NCT01198301
- Acronym / sponsor ID
- GEP
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- Metastatic Breast Neoplasms, Gene Expression Profiling, Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Sep 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 investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.
Detailed description
- Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.
- After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours.
- The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups
- Statistical analysis is performed using unsupervised hierarchical cluster.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy
Key inclusion criteria (7 listed)
- Patients should be histologically confirmed with metastatic breast cancer;
- Patients who had completed the planned chemotherapy regimen with no major protocol violation;
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- At least one measurable lesion;
- Normal cardiac, hepatic, renal and bone marrow functions;
Key exclusion criteria (4 listed)
- previous history of other malignancies;
- previous surgery history on the needle biopsy organ;
- Central nervous system metastases;
- Serious or uncontrolled concurrent medical illness.
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
Chemotherapy response
Time frame: four-months
Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines
3 secondary outcomes
Time to disease progression
Time frame: six months
Overall survival
Time frame: one year
clinical benefit response
Time frame: six months to one year
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 23 Jul 2015.
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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.
Zheng Wang, PhD principal investigator
Peking University Cancer Hospital & Institute
Jun Ren, MD study chair
Peking University Cancer Hospital & Institute
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 Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute 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 7 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 23 Jul 2015. 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?
Chemotherapy response (time frame: four-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 23 Jul 2015.