Triple Negative Breast CancerPhase 1DecipHERNCT05504707
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
A Phase 1 study testing HER2 - primed Dendritic cells and HER3 - primed Dendritic cells in people with Triple Negative Breast Cancer and HER2-negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- HER2 - primed Dendritic cells and HER3 - primed Dendritic cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of HER2-negative breast cancer.
- Diagnosis of HR negative or HR low positive tumor.
- Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
- Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician.
- Age ≥18 years.
- ECOG performance status 0 or 1.
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- Patients must have normal organ and marrow function, as defined below, within 14 days of registration:
- *Absolute neutrophil count (ANC) ≥ 1500/μL
- *Platelets ≥ 75 000/μL
- *Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL
- *AST/ALT ≤ 3 x institutional ULN
- *Creatinine ≤ 1.5 x institutional ULN
- Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan).
- Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (and not because of/following chemotherapy) or patients must be surgically sterile.
- Ability to understand and the willingness to sign a written informed consent agreement prior to study registration.
Who cannot join
- Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer.
- Patients with inflammatory breast cancer.
- Patients must not be receiving any other investigational agents or active antineoplastic therapies.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).
- Female patients who are pregnant or nursing.
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- No other prior malignancy is allowed, except for the following: a. adequately treated basal-cell or squamous-cell skin cancer, b. in situ cervical cancer, c. or any other cancer from which the patient has been disease free for at least 3 years.
- History of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- History of positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection.
- Patients who have received a live attenuated vaccine ≤ 30 days prior to registration.
- Unable to comply with the treatment schedule and study procedures for any reason.
- Previously treated with breast cancer-directed vaccine therapies in prior 3 months.
- Previously treated with any form HER2- or HER3-primed DC1 therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Shere Wallace-Morrison, 813-745-7962, Shere.Wallace-Morrison@moffitt.org
Ricardo Costa, MD, MSc
About this study
Official title: Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
- Being tested
- HER2 - primed Dendritic cells, HER3 - primed Dendritic cells
- Keywords
- Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 - primed Dendritic cellsBiological
Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs.
Participants will be treated at the following dose levels:
Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells dose 80-100 million
HER3 - primed Dendritic cellsBiological
Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs.
Participants will be treated at the following dose levels:
Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells dose 80-100 million
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cell Vaccine dose Escalation | Experimental | Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used. Receives: Biological: HER2 - primed Dendritic cells; Biological: HER3 - primed Dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Maximum Tolerated Dose (MTD) of HER2- and HER3- primed DC1 study vaccines. The MTD will be defined as the highest dose level at which < 2 of 6 patients experience dose-limiting toxicities (DLTs).
Measured: 4 weeks after start of treatment
Secondary outcomes (7)
Number of Dose Limiting Toxicities
Number of DLTs experienced by participants
Measured: 5 weeks after start of treatment
Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections
Pathological complete response defined as the absence of invasive breast cancer in the breast and lymph nodes after completion of treatment with DC1 injections and neoadjuvant chemotherapy.
Measured: Up to 24 weeks
Participants with clinical and radiological responses after receiving HER2/HER3 DC1
Clinical or radiological complete responses (CR): Palpable or visible lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression.
Measured: Up to 36 Months
Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1
Clinical or radiological partial responses (PR): A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more.
Measured: Up to 36 Months
Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1
Clinical or radiological progression of disease (PD): An increase in the product of the two largest perpendicular diameters of the primary tumor by 25% or more or the presence of a new lesion.
Measured: Up to 36 Months
Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1
Clinical or radiological stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Up to 36 Months
Participants with Recurrence Free Survival (RFS)
Recurrence free survival (RFS) defined as time I months to breast cancer recurrence or death (whichever comes first) since date of surgical treatment of breast cancer.
Measured: Up to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start26 Aug 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Shulas' Foundation
- Responsible party
- Sponsor
- Investigators
- Ricardo Costa, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504707
- Sponsor's protocol ID
- MCC-20897
- Acronym
- DecipHER
- Status last verified
- Feb 2026
- First submitted
- 15 Aug 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)
- ClinicalTrials.gov ID
- NCT05504707
- Acronym / sponsor ID
- DecipHER / MCC-20897
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- The Shulas' Foundation
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Aug 2022 (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 the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cell Vaccine dose Escalation | Experimental | Biological: HER2 - primed Dendritic cells, Biological: HER3 - primed Dendritic cellsDose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A diagnosis of HER2-negative breast cancer.
- Diagnosis of HR negative or HR low positive tumor.
- Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
- Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician.
- Age ≥18 years.
Key exclusion criteria (13 listed)
- Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer.
- Patients with inflammatory breast cancer.
- Patients must not be receiving any other investigational agents or active antineoplastic therapies.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).
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 - primed Dendritic cellsDendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells dose 80-100 million | Biological | Dendritic Cell Vaccine dose Escalation |
| HER3 - primed Dendritic cellsDendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells dose 80-100 million | Biological | Dendritic Cell Vaccine dose Escalation |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 4 weeks after start of treatment
Maximum Tolerated Dose (MTD) of HER2- and HER3- primed DC1 study vaccines. The MTD will be defined as the highest dose level at which < 2 of 6 patients experience dose-limiting toxicities (DLTs).
7 secondary outcomes
Number of Dose Limiting Toxicities
Time frame: 5 weeks after start of treatment
Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections
Time frame: Up to 24 weeks
Participants with clinical and radiological responses after receiving HER2/HER3 DC1
Time frame: Up to 36 Months
Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1
Time frame: Up to 36 Months
Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1
Time frame: Up to 36 Months
Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1
Time frame: Up to 36 Months
Participants with Recurrence Free Survival (RFS)
Time frame: Up to 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ricardo Costa, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HER2 - primed Dendritic cells and HER3 - primed Dendritic cells in people with Triple Negative Breast Cancer and HER2-negative 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 15 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Costa (813-745-5051, Ricardo.Costa@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 4 weeks after start of treatment). 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 5 Feb 2026.