Breast CancerPhase 2NCT03630809
Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1
A Phase 2 study testing HER2 DC1 Vaccine in people with Breast Cancer and HER2-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, HER-2 Gene Amplification
- What is being tested?
- HER2 DC1 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2019to 11 Apr 2022
- Phase
- Phase 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of nonmetastatic or metastatic breast cancer in complete clinicla response classic HER2pos (ie, IHC 3+ or FISHpos) breast cancer (BC) who have previously been vaccinated with DC1 HER2-pulsed vaccines on any of several prior clinical trials for ductal carcinoma in situ (DCIS) or inflammatory breast cancer (IBC) are eligible; however, we also allowed HER2 2+ patients in many of these prior trials and they will also be allowed to participate in this trial. Note: HER2pos BC is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification. The lack of HER2 overexpression by IHC is defined as 0 or 1+ whereas overexpression is defined as 3+. In the event of equivocal IHC, 2+, the tumor must be gene-amplified by fluorescent in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio > 2 and HER2 copy number > 4 define HER2negdisease).
- Patients with nonmetastatic HER posBC must have completed all standard-of-care treatment for nonmetastatic BC (e.g., surgery, chemotherapy, radiation therapy, and HER2-targeted therapy). Note: antiestrogen therapy is permitted while on trial. Note: antiestrogen therapy is permitted while on trial.
- Patients with diagnosis of metastatic HER2 pos breast cancer must have complete tumor response to current treatment per RECIST 1.1 and completed all standard-of-care chemotherapy. Note: maintenance treatment with approved HER2-targeted agents and/or antiestrogen therapy is permitted while on trial.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Participants must have normal organ and marrow function within 2 weeks of registration.
- For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose.
- Must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Uncontrolled congenital or acquired immune deficiency that is requiring treatment that would interfere with study treatment will not be allowed on study. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded.
- No other prior malignancy is allowed except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Any other cancer from which the patient has been disease free for at least 3 years.
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- Pregnant or breast feeding.
- Known to be HIV positive.
- Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
- Major surgery within 4 weeks of initiation of study drug.
- Have not recovered to ≤ Grade 1 or tolerable Grade 2 adverse events (AEs) due to agents administered ≥ 28 days earlier, as documented by the treating investigator.
- Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug. Note: patients enrolled on another HER2 vaccine trial but not receiving active therapy can enroll in this study.
- Not able to comply with the treatment schedule and study procedures for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine
The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines.
There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence.
This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, HER-2 Gene Amplification, HER2 Positive Breast Carcinoma, HER-2 Protein Overexpression, Breast Cancer, Male
- Being tested
- HER2 DC1 Vaccine
- Keywords
- nonmetastatic, classic HER2, Nonmetastatic classic HER2
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 DC1 VaccineBiological
Also called Vaccine
Ultrasound (US) guided intranodal delivered vaccines will be administered at each participating site by a radiologist experienced in ultrasound guided procedures along with the principal investigator or his/her designee. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1 right and 1 left normal groin lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Previously enrolled in study or have been previously treated with DC1 Vaccines - Arm A | Active comparator | Participants currently enrolled into arm A will offered randomization into arms C or D. If study participants decline randomization or are ineligible, they will complete study follow up visits as stated in the schedule of events per Arm A. Receives: Biological: HER2 DC1 Vaccine |
| Participants receiving first 3 boosters at 3 month intervals - Arm B | Active comparator | A history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented. Patient currently enrolled into arm B will offered randomization into arms C or D once finished with arm B. If patients decline randomization or are ineligible, they will complete study follow up visits as stated in the schedule of events per Arm B. Receives: Biological: HER2 DC1 Vaccine |
| Participants receiving 3 booster vaccines at 3-month intervals (+/- 30 days window) - Arm C | Experimental | A history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented Receives: Biological: HER2 DC1 Vaccine |
| Participants receiving 6 booster vaccines at 3-month intervals (+/- 30 days window) - Arm D | Experimental | A history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented. Receives: Biological: HER2 DC1 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2 DC1 Vaccine Regimen
Investigators will assess the feasibility of participants receiving the six-booster regimen if 11/15 randomized to Arm D complete all 6 booster injections.
Measured: Up to 16 months
Secondary outcomes (9)
HER2 Immunity with 3 Booster Regimen at 18 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at 18 months from month 1 injection. treatment among women with breast cancer previously treated with HER2 vaccines. Two regimens consist of 3 versus 6 booster HER2 vaccine injections administered every 3 months
Measured: At 18 months after first dose
HER2 Immunity with 6 Booster Regimen at 18 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at 18 months from month 1 injection. treatment among women with breast cancer previously treated with HER2 vaccines. Two regimens consist of 3 versus 6 booster HER2 vaccine injections administered every 3 months
Measured: At 18 months after first dose
HER2 Immunity with 3 Booster Regimen at 10 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at month 10 from first vaccine treatment
Measured: At 10 months after first dose
HER2 Immunity with 6 Booster Regimen at 10 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at month 10 from first vaccine treatment
Measured: At 10 months after first dose
Rate of Treatment Emergent Adverse Events of 3 Dose Regimen
Serious adverse events will be recorded for 100 days after study treatment. Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 5 years
Rate of Treatment Emergent Adverse Events of 6 Dose Regimen
Serious adverse events will be recorded for 100 days after study treatment. Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 5 years
Overall Survival
OS will be measured using the Kaplan-Meier method
Measured: Up to 5 Years
Disease Free Survival
DFS will be measured using the Kaplan-Meier method
Measured: Up to 5 Years
Progression Free Survival
PFS will be measured using the Kaplan-Meier method
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Jan 2019
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Why it stopped: Quality of the data originating from prior versions of the protocol has been affected by protocol deviations triggered by the COVID-19 pandemics
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.
- More trials run by H. Lee Moffitt Cancer Center and Research 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Costa, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630809
- Sponsor's protocol ID
- MCC-19650
- Status last verified
- Apr 2022
- First submitted
- 10 Aug 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine
- ClinicalTrials.gov ID
- NCT03630809
- Acronym / sponsor ID
- MCC-19650
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, HER-2 Gene Amplification, HER2 Positive Breast Carcinoma, HER-2 Protein Overexpression, Breast Cancer, Male
- Keywords
- nonmetastatic, classic HER2, Nonmetastatic classic HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Quality of the data originating from prior versions of the protocol has been affected by protocol deviations triggered by the COVID-19 pandemics
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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 learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines.
There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence.
This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Previously enrolled in study or have been previously treated with DC1 Vaccines - Arm A | Active comparator | Biological: HER2 DC1 VaccineParticipants currently enrolled into arm A will offered randomization into arms C or D. If study participants decline randomization or are ineligible, they will complete study follow up visits as stated in the schedule of events per Arm A. |
| Participants receiving first 3 boosters at 3 month intervals - Arm B | Active comparator | Biological: HER2 DC1 VaccineA history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented. Patient currently enrolled into arm B will offered randomization into arms C or D once finished with arm B. If patients decline randomization or are ineligible, they will complete study follow up visits as stated in the schedule of events per Arm B. |
| Participants receiving 3 booster vaccines at 3-month intervals (+/- 30 days window) - Arm C | Experimental | Biological: HER2 DC1 VaccineA history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented |
| Participants receiving 6 booster vaccines at 3-month intervals (+/- 30 days window) - Arm D | Experimental | Biological: HER2 DC1 VaccineA history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a diagnosis of nonmetastatic or metastatic breast cancer in complete clinicla response classic HER2pos (ie, IHC 3+ or FISHpos) breast cancer (BC) who have previously been vaccinated with DC1 HER2-pulsed vaccines on any of several prior clinical trials for ductal carcinoma in situ (DCIS) or inflammatory breast cancer (IBC) are eligible; however, we also allowed HER2 2+ patients in many of these prior trials and they will also be allowed to participate in this trial. Note: HER2pos BC is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification. The lack of HER2 overexpression by IHC is defined as 0 or 1+ whereas overexpression is defined as 3+. In the event of equivocal IHC, 2+, the tumor must be gene-amplified by fluorescent in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio > 2 and HER2 copy number > 4 define HER2negdisease).
- Patients with nonmetastatic HER posBC must have completed all standard-of-care treatment for nonmetastatic BC (e.g., surgery, chemotherapy, radiation therapy, and HER2-targeted therapy). Note: antiestrogen therapy is permitted while on trial. Note: antiestrogen therapy is permitted while on trial.
- Patients with diagnosis of metastatic HER2 pos breast cancer must have complete tumor response to current treatment per RECIST 1.1 and completed all standard-of-care chemotherapy. Note: maintenance treatment with approved HER2-targeted agents and/or antiestrogen therapy is permitted while on trial.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (13 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Uncontrolled congenital or acquired immune deficiency that is requiring treatment that would interfere with study treatment will not be allowed on study. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded.
- No other prior malignancy is allowed except for the following:
- Pregnant or breast feeding.
- Known to be HIV positive.
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 |
|---|---|---|
| HER2 DC1 VaccineAlso: VaccineUltrasound (US) guided intranodal delivered vaccines will be administered at each participating site by a radiologist experienced in ultrasound guided procedures along with the principal investigator or his/her designee. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1 right and 1 left normal groin lymph nodes. | Biological | Participants receiving 3 booster vaccines at 3-month intervals (+/- 30 days window) - Arm C, Participants receiving 6 booster vaccines at 3-month intervals (+/- 30 days window) - Arm D, Participants receiving first 3 boosters at 3 month intervals - Arm B, Previously enrolled in study or have been previously treated with DC1 Vaccines - Arm A |
Primary outcome
HER2 DC1 Vaccine Regimen
Time frame: Up to 16 months
Investigators will assess the feasibility of participants receiving the six-booster regimen if 11/15 randomized to Arm D complete all 6 booster injections.
9 secondary outcomes
HER2 Immunity with 3 Booster Regimen at 18 months
Time frame: At 18 months after first dose
HER2 Immunity with 6 Booster Regimen at 18 months
Time frame: At 18 months after first dose
HER2 Immunity with 3 Booster Regimen at 10 months
Time frame: At 10 months after first dose
HER2 Immunity with 6 Booster Regimen at 10 months
Time frame: At 10 months after first dose
Rate of Treatment Emergent Adverse Events of 3 Dose Regimen
Time frame: Up to 5 years
Rate of Treatment Emergent Adverse Events of 6 Dose Regimen
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 Years
Disease Free Survival
Time frame: Up to 5 Years
Progression Free Survival
Time frame: Up to 5 Years
Results and safety
The study was stopped early (reason given: Quality of the data originating from prior versions of the protocol has been affected by protocol deviations triggered by the COVID-19 pandemics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Ricardo Costa, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HER2 DC1 Vaccine in people with Breast Cancer and HER2-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 Apr 2022. 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 United States. 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 phase mean?
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 stopped early (reason given: Quality of the data originating from prior versions of the protocol has been affected by protocol deviations triggered by the COVID-19 pandemics). Results are not available in the source record.
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?
HER2 DC1 Vaccine Regimen (time frame: Up to 16 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 25 Apr 2022.