Breast CancerPhase 1/2NCT02547961
Chimeric Antigen Receptor-Modified T Cells for Breast Cancer
A Phase 1/2 study testing HER-2-targeting CAR T Cells infusion in people with Breast Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HER-2-targeting CAR T Cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to 15 Aug 2016
- Phase
- Phase 1/2
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chemotherapy refractory Her2 positive breast cancer；
- Relapsed patients after anti-Her2 using antibody or kinase inhibitor therapy；
- Patients must be 18 years of age or older；
- Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2；
- Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
- Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
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- Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
- Seronegative for HIV antibody.
- Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
- Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
- Patients must be willing to sign an informed consent.
Who cannot join
- 1. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- 2.Patients with any of the follo wing pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- 3.Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- 4.Pregnant and/or lactating women will be excluded. 5.Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
- 6.Patients with any type of primary immunodeficiencies will be excluded from the study.
- 7.Patients requiring corticosteroids (other than inhaled) will be excluded. 8.Patients with history of T cell tumors will be excluded. 9.Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Chimeric Antigen Receptor-Modified T Cells for HER-2 Positive Recurrent and Metastatic Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer.
Read the detailed description
By enrolling patients with advanced HER2 positive breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HER2-CAR-T cell infusion for advanced HER2 positive breast cancer.The CAR consists of a HER-2 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
- Conditions
- Breast Cancer
- Being tested
- HER-2-targeting CAR T Cells infusion
- Keywords
- breast cancer, HER2, CAR-T cell
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2-targeting CAR T Cells infusionBiological
HER-2-targeting CAR t cells infusion in breast cancer
| Study group | Role | What they receive |
|---|---|---|
| HER2-CAR-T | Experimental | In interventional studies, participants are assigned to accept HER-2-targeting CAR T Cells infusion so that researchers can evaluate the effects and safety of the CAR-T cell. Receives: Biological: HER-2-targeting CAR T Cells infusion |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Measured: 24weeks
Secondary outcomes (1)
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion15 Aug 2016
- Study completion15 Aug 2016
Why it stopped: Project terminated due to revision of local regulations
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, PhD, Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547961
- Sponsor's protocol ID
- Breast Cancer CAR-T 001
- Status last verified
- Jul 2020
- First submitted
- 4 Sep 2015
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chimeric Antigen Receptor-Modified T Cells for HER-2 Positive Recurrent and Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02547961
- Acronym / sponsor ID
- Breast Cancer CAR-T 001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, HER2, CAR-T cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project terminated due to revision of local regulations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 14 Sep 2015 (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 purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer.
Detailed description
By enrolling patients with advanced HER2 positive breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HER2-CAR-T cell infusion for advanced HER2 positive breast cancer.The CAR consists of a HER-2 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2-CAR-T | Experimental | Biological: HER-2-targeting CAR T Cells infusionIn interventional studies, participants are assigned to accept HER-2-targeting CAR T Cells infusion so that researchers can evaluate the effects and safety of the CAR-T cell. |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chemotherapy refractory Her2 positive breast cancer；
- Relapsed patients after anti-Her2 using antibody or kinase inhibitor therapy；
- Patients must be 18 years of age or older；
- Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2；
- Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
Key exclusion criteria (6 listed)
- 1. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- 2.Patients with any of the follo wing pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- 3.Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- 4.Pregnant and/or lactating women will be excluded. 5.Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
- 6.Patients with any type of primary immunodeficiencies will be excluded from the study.
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 |
|---|---|---|
| HER-2-targeting CAR T Cells infusionHER-2-targeting CAR t cells infusion in breast cancer | Biological | HER2-CAR-T |
Primary outcome
Number of participants with Adverse events
Time frame: 24weeks
1 secondary outcome
Tumor load
Time frame: 24weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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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.
Lizhi Niu, PhD study chair
Fuda Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HER-2-targeting CAR T Cells infusion in people with Breast Cancer, run by Fuda Cancer Hospital, Guangzhou 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 11 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: withdrawn, as of the sponsor's last update on 16 Jul 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with Adverse events (time frame: 24weeks). 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 16 Jul 2020.