Breast CancerPhase 1/2NCT02336984
A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
A Phase 1/2 study testing HER-2 pulsed DC1, trastuzumab and pertuzumab in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HER-2 pulsed DC1, trastuzumab and pertuzumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 4 Apr 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women >= 18 years.
- Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
- Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
- Women of childbearing age with a negative pregnancy test documented prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
- Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Who cannot join
- Pregnant or lactating.
- Positive for HIV or hepatitis C at baseline by self-report.
- Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec
- Major cardiac illness MUGA or ECHO <50% EF.
- Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.
- Conditions
- Breast Cancer
- Being tested
- HER-2 pulsed DC1, trastuzumab, pertuzumab
- Keywords
- Ductal carcinoma in situ (DCIS)
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2 pulsed DC1Biological
Also called vaccine
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
trastuzumabDrug
Also called Herceptin
The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.
pertuzumabDrug
Also called Perjeta
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab. Receives: Biological: HER-2 pulsed DC1; Drug: trastuzumab; Drug: pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Related Adverse Events (AEs)
Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJun 2014
- Primary completion4 Apr 2016
- Study completion4 Apr 2016
Why it stopped: PI left Abramson Cancer Center and study never opened at Moffitt Cancer Center.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Czerniecki, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336984
- Sponsor's protocol ID
- UPCC 03114
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2015
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
- ClinicalTrials.gov ID
- NCT02336984
- Acronym / sponsor ID
- UPCC 03114
- Conditions
- Breast Cancer
- Keywords
- Ductal carcinoma in situ (DCIS)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left Abramson Cancer Center and study never opened at Moffitt Cancer Center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 4 Apr 2016 (actual)
- Study completion
- 4 Apr 2016 (actual)
- First posted
- 13 Jan 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 the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Biological: HER-2 pulsed DC1, Drug: trastuzumab, Drug: pertuzumabCombination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women >= 18 years.
- Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
- Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
- Women of childbearing age with a negative pregnancy test documented prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
Key exclusion criteria (5 listed)
- Pregnant or lactating.
- Positive for HIV or hepatitis C at baseline by self-report.
- Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec
- Major cardiac illness MUGA or ECHO <50% EF.
- Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
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 pulsed DC1Also: vaccineVaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines. | Biological | Combination Therapy |
| trastuzumabAlso: HerceptinThe loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab. | Drug | Combination Therapy |
| pertuzumabAlso: PerjetaPertuzumab 420 mg IV will be given at the same time as trastuzumab. | Drug | Combination Therapy |
Primary outcome
Occurrence of Related Adverse Events (AEs)
Time frame: 5 years
Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.
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 11 Jan 2021.
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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.
Brian Czerniecki, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites 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 pulsed DC1, trastuzumab and pertuzumab in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 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: withdrawn, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Occurrence of Related Adverse Events (AEs) (time frame: 5 years). 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 11 Jan 2021.