Breast CancerPhase 1NCT06949410
HER2 Vaccine for Locally Advanced Breast Cancer
A Phase 1 study testing HER2 Vaccine in people with Breast Cancer and HER2-positive Breast Cancer, run by Pravin T.P Kaumaya at 1 site in United States.
Trial summary
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- HER2 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Mar 2030
- 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
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864
- Histologically confirmed HER2 positive breast cancer
- Any Estrogen Receptor/Progesterone Receptor status is allowed.
- HER2 positive is defined as HER2 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of > 2.0 or > 6 total HER2 gene copies per cell.
- High-risk disease defined as one of the following:
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- Any residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant taxane and trastuzumab-based chemotherapy
- Inflammatory phenotype at the time of diagnosis per the treating physician
- Clinical stage III disease at the time of diagnosis per the treating physician and/or clinical imaging
- Locally recurrent disease and have undergone definitive local therapy
- Received at least six months of HER2 targeted therapy with trastuzmab +/- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting
- Any combination of HER2 targeted therapy in the curative setting is allowed, including neratinib or others on a clinical trial
- Completed last dose of HER2 targeted therapy no more than 6 months prior to registration
- Completed last dose of cytotoxic chemotherapy or radiation at least 30 days prior to registration with resolution of any prior toxicity to ≤ 2 with the exception of alopecia
- ECOG performance status of 0 to 2
- Adequate organ function as indicated by:
- Total bilirubin < 1.5 mg/dL (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.0 x ULN
- Calculated creatinine clearance of > 60 mL/min using the Cockcroft-Gault formula
- Absolute neutrophil count (ANC) > 1.0 K/mm3
- Platelets > 100 K/ mm3
- Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
- Has undergone a hysterectomy or bilateral oophorectomy; or
- Has been naturally amenorrheic for at least 12 consecutive months.
- Women of childbearing potential and men must agree to use one effective contraception throughout the study and for 6 months after the last study treatment.
- Note: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).
Who cannot join
- Any distant disease recurrence.
- Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.
- Patients receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
- Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
- Patients who require or likely to require corticosteroids or other immunosuppressives
- Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.
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- Note: At the discretion of the treating physician, patients who show disease control for at least 6 months and do not require immunosuppressives may be enrolled.
- Patients who have developed anaphylactic responses to other vaccines.
- Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.
- Known seropositive or active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV). Seropositivity due to vaccination are eligible.
- Uncontrolled illness that would limit safety or compliance with study procedures including, but not limited to, active infection, congestive heart failure, unstable angina, or cardiac arrhythmia.
- Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.
- History of splenectomy
- Pregnant or breast feeding.
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
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Niraj Shah, 317-278-3420, shahnir@iu.edu
Pravin Kaumaya, PhD
About this study
Official title: Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 51 Adjuvant for Locally Advanced HER2 Positive Breast Cancer
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- HER2 Vaccine
- Keywords
- vaccine, immune system, immunotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 VaccineDrug
MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines
| Study group | Role | What they receive |
|---|---|---|
| HER2 Vaccine Arm | Experimental | MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered intramuscularly in the gluteus maximus once every 21 days for three doses, in alternating sides (i.e. left->right->left), with a booster administered at 6 months. Receives: Drug: HER2 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0
Number of adverse events as assessed by the NCI CTCAE v. 5.0
Measured: through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)
Immune Response
Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296).
Measured: through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionMar 2030 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pravin T.P Kaumaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pravin T.P Kaumaya, Indiana University
- Investigators
- Pravin Kaumaya, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949410
- Sponsor's protocol ID
- CTO-IUSCCC-0864
- Status last verified
- Nov 2026
- First submitted
- 22 Apr 2025
- Last updated
- 5 Nov 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 51 Adjuvant for Locally Advanced HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06949410
- Acronym / sponsor ID
- CTO-IUSCCC-0864
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Keywords
- vaccine, immune system, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pravin T.P KaumayaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 29 Apr 2025 (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 goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 Vaccine Arm | Experimental | Drug: HER2 VaccineMVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered intramuscularly in the gluteus maximus once every 21 days for three doses, in alternating sides (i.e. left->right->left), with a booster administered at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864
- Histologically confirmed HER2 positive breast cancer
- High-risk disease defined as one of the following:
- Received at least six months of HER2 targeted therapy with trastuzmab +/- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting
Key exclusion criteria (14 listed)
- Any distant disease recurrence.
- Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.
- Patients receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
- Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
- Patients who require or likely to require corticosteroids or other immunosuppressives
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 VaccineMVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines | Drug | HER2 Vaccine Arm |
Primary outcome
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0
Time frame: through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)
Number of adverse events as assessed by the NCI CTCAE v. 5.0
Immune Response
Time frame: through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)
Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296).
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 Nov 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.
Pravin Kaumaya, PhD principal investigator
Indiana University
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 Vaccine in people with Breast Cancer and HER2-positive Breast Cancer, run by Pravin T.P Kaumaya 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 27 inclusion and 14 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 Nov 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 Niraj Shah (317-278-3420, shahnir@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0 (time frame: through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)). The study lists 2 primary outcomes in all. 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 Nov 2026.