Breast NeoplasmsDC-CIKNCT01232062
Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
An observational study of Breast Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Oct 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: female patients with metastatic breast cancer
Who may be able to join
- Failure to anthracycline and/or taxol chemotherapy;
- metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
- Metastatic tumor can not be removed through surgery procedure;
- Metastatic tumor measured by PET-CT scan is at least 1cm;
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Normal cardiac, hepatic, renal and bone marrow functions;
- Life expectancy ≥3 months.
Who cannot join
- Do not finish twice PET-CT scan;
- Central nervous system metastases;
- Serious or uncontrolled concurrent medical illness;
- History of other malignancies;
- Having been enrolled in some other clinal trials within a month;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients
Read the detailed description
- Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
- All the patients enrolled will be given standard HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
- PET-CT scans were done on each patients at baseline and after chemotherapy. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
- Estimate time to progression, survival rates and clinical benefit response on patients.
- Find biomarkers associated with drug response.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- breast neoplasm, Neoplasm Metastasis, 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.
response to chemotherapy
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
Measured: 4months
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 to one year
survival rates
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 posted2 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionOct 2013
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
- Retrospective
- Enrolment
- 46 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
- JING YU, MD, PhD, Principal investigator, Peking University Cancer Hospital & InstituteCHAO YING WANG, MD, PhD, Principal investigator, Peking University Cancer Hospital & InstituteJUN REN, MD, PhD, Study chair, Peking University Cancer Hospital & InstituteYU LIN ZHU, MD, PhD, Principal investigator, Bei jing Cancer HospitalJie Zhang, MD., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232062
- Sponsor's protocol ID
- HD+DC-CIK
- Acronym
- DC-CIK
- Status last verified
- Jul 2015
- First submitted
- 29 Oct 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
- Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01232062
- Acronym / sponsor ID
- DC-CIK / HD+DC-CIK
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- breast neoplasm, Neoplasm Metastasis, Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Nov 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.
To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients
Detailed description
- Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
- All the patients enrolled will be given standard HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
- PET-CT scans were done on each patients at baseline and after chemotherapy. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
- Estimate time to progression, survival rates and clinical benefit response on patients.
- Find biomarkers associated with drug response.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female patients with metastatic breast cancer
Key inclusion criteria (7 listed)
- Failure to anthracycline and/or taxol chemotherapy;
- metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
- Metastatic tumor can not be removed through surgery procedure;
- Metastatic tumor measured by PET-CT scan is at least 1cm;
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Key exclusion criteria (5 listed)
- Do not finish twice PET-CT scan;
- Central nervous system metastases;
- Serious or uncontrolled concurrent medical illness;
- History of other malignancies;
- Having been enrolled in some other clinal trials within a month;
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
response to chemotherapy
Time frame: 4months
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
3 secondary outcomes
Time to disease progression
Time frame: six months to one year
survival rates
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.
JING YU, MD, PhD principal investigator
Peking University Cancer Hospital & Institute
CHAO YING WANG, MD, PhD principal investigator
Peking University Cancer Hospital & Institute
JUN REN, MD, PhD 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 5 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?
response to chemotherapy (time frame: 4months). 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.