Breast Ductal Carcinoma In SituPhase 1NCT04144023
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
A Phase 1 study testing Granulocyte-Macrophage Colony-Stimulating Factor, Multi-epitope HER2 Peptide Vaccine H2NVAC and Therapeutic Conventional Surgery in people with Breast Ductal Carcinoma In Situ, run by Mayo Clinic at 2 sites in United States.
Trial summary
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Ductal Carcinoma In Situ
- What is being tested?
- Granulocyte-Macrophage Colony-Stimulating Factor, Multi-epitope HER2 Peptide Vaccine H2NVAC and Therapeutic Conventional Surgery
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2019to 31 Dec 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Patients must not have received any prior therapy for current DCIS
- Note: Patients who received tamoxifen, raloxifene, aromatase inhibitor or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least 2 months prior to baseline study biopsy if they chose to have this collected
- Note: Concurrent use of endocrine therapy during the vaccination/preoperative period is not allowed. However, standard adjuvant endocrine therapy with tamoxifen or aromatase inhibitor after completion of vaccination and surgery is allowed
- Any degree of HER2 expression as performed on the diagnostic clinical biopsy defined by immunohistochemistry +1, +2, or +3
- Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis
Show all 23Show fewer
- Note: suspected microinvasion or definite microinvasion (< 0.1 mm invasion) on core biopsy is allowed
- Patients will be asked to have an additional research biopsy prior to the first vaccination. This is not mandatory for participation
- Patients must have evidence of at least 0.5 cm of disease extent based on mammogram, ultrasound, or magnetic resonance (MRI) imaging
- Absolute neutrophil count (ANC) >= 1500/mm^3 (less than or equal to 28 days prior to registration)
- Platelet count >= 75,000/mm^3 (less than or equal to 28 days prior to registration)
- Hemoglobin >= 9.0 g/dL (less than or equal to 28 days prior to registration)
- Creatinine =< 2 x upper limit of normal (ULN) (less than or equal to 28 days prior to registration)
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x ULN (less than or equal to 28 days prior to registration)
- Albumin >= 3 g/dL (less than or equal to 28 days prior to registration)
- Negative serum pregnancy test done =< 7 days prior to Registration, for women of childbearing potential only
- Willing to employ adequate contraception from the time of Registration through 6 months after the final vaccine cycle
- Note: Adequate contraception methods include birth control pills, barrier device, intrauterine device, or abstinence
- Capable of understanding the investigative nature, potential risks, and benefits of the study
- Capable of providing valid informed consent
- Willing to return to enrolling institution for all study visits (immunizations, blood draws, etc)
- Willing to provide blood samples for correlative research purposes
- Willing to receive a tetanus vaccination if subject has not had one within the past year
Who cannot join
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women unwilling to stop breast feeding
- Women of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids, unless physiologic replacement for adrenal or pituitary insufficiency
Show all 23Show fewer
- Note: Must be off systemic steroids greater than or equal to 90 days prior to Registration. However, topical steroids, inhalants or steroid eye drops are permitted
- 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
- Uncontrolled acute or chronic medical conditions including, but not limited to the following:
- Active infection requiring antibiotics
- Congestive heart failure with New York Heart Association class III or IV moderate to severe objective evidence of cardiovascular disease
- Myocardial infarction or stroke less than or equal to 6 months prior to registration
- Receiving any other investigational agent
- Other active malignancy at time of registration or less than or equal to the last three years prior to registration. EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
- NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for their cancer
- Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration
- NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded
- Any prior hypersensitivity or adverse reaction to GM-CSF
- History of trastuzumab-related cardiac toxicity requiring interruption or discontinuation of therapy, even if left ventricular ejection fraction (LVEF) fully recovered
- Baseline LVEF with a value below 55%
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- History of myocardial infarction =< 168 days (6 months) prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias
- History of ipsilateral radiation to the current affected breast with DCIS
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-766-0015, mayocliniccancerstudies@mayo.edu
Saranya Chumsri, M.D.
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Amy C. Degnim, M.D.
About this study
Official title: A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of multi-epitope HER2 peptide vaccine H2NVAC (H2NVAC) given for 4 treatments in patients with HER2-expressing ductal carcinoma in situ (DCIS) prior to surgery.
II. To determine the dose level of H2NVAC with maximum systemic and intratumoral immunogenicity as measured by activated HER2-specific T lymphocytes or high-affinity antibodies.
SECONDARY OBJECTIVES:
- To determine intratumoral immunogenicity of H2NVAC in patients with HER2-expressing DCIS.
II. To assess the complete pathological response after 4 treatments of neoadjuvant H2NVAC.
III. To assess the systemic immunogenicity of H2NVAC in patients with HER2-expressing DCIS.
IV. To assess changes in HER2 expression in the DCIS after 4 treatments of neoadjuvant H2NVAC.
- To assess the distribution of the helper T cell response among T helper cell differentiation states.
OUTLINE: This is a dose-escalation study of multi-epitope HER2 peptide vaccine H2NVAC followed by a dose expansion study for dose level.
Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive granulocyte macrophage-colony-stimulating factor (GM-CSF) admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo echocardiography (ECHO) and collection of blood samples throughout the trial and may undergo biopsy on trial.
After completion of study treatment, patients are followed up at 3, 6, and 12 months after surgery and optionally at 18 and 24 months after surgery.
- Conditions
- Breast Ductal Carcinoma In Situ
- Being tested
- Granulocyte-Macrophage Colony-Stimulating Factor, Multi-epitope HER2 Peptide Vaccine H2NVAC, Therapeutic Conventional Surgery, Echocardiography Test, Biospecimen Collection
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte-Macrophage Colony-Stimulating FactorBiological
Also called Colony Stimulating Factor 2, Colony Stimulating Factor, Granulocyte-Macrophage, Colony-Stimulating Factor, Colony-Stimulating Factor 2
Given intradermally
Multi-epitope HER2 Peptide Vaccine H2NVACBiological
Also called H2NVAC, HER2 Peptide Vaccine H2NVAC, HER2 Specific Helper T-cell Epitope Vaccine H2NVAC
Given intradermally
Therapeutic Conventional SurgeryProcedure or surgery
Undergo standard of care surgery
Echocardiography TestProcedure or surgery
Also called EC, ECHOCARDIOGRAPHY, ECHO
Undergo ECHO
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Biopsy ProcedureProcedure or surgery
Also called BIOPSY, BIOPSY_TYPE
Undergo biopsy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) | Experimental | Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo ECHO and collection of blood samples throughout the trial and may undergo biopsy on trial. Receives: Biological: Granulocyte-Macrophage Colony-Stimulating Factor; Biological: Multi-epitope HER2 Peptide Vaccine H2NVAC; Procedure: Therapeutic Conventional Surgery; Procedure: Echocardiography Test; Procedure: Biospecimen Collection; Procedure: Biopsy Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Measured: 2 years
Dose limiting toxicities
Measured using criteria from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 with grade >= 3 allergic reaction, grade >= 3 autoimmune reaction (except for autoimmune encephalitis grade >=4), grade >= 3 injection site reaction manifesting as an ulceration, grade >= 3 neurologic problem, grade >= 3 non-hematologic or cardiac toxicity, or changes in left ventricular ejection fraction (LVEF) as specified per protocol.
Measured: 14 days post vaccination, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start27 Jun 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Ductal Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy C. Degnim, Mayo Clinic
- Investigators
- Amy C. Degnim, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144023
- Sponsor's protocol ID
- MC1713
- Other IDs
- NCI-2019-07002, 16-010561
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS
- ClinicalTrials.gov ID
- NCT04144023
- Acronym / sponsor ID
- MC1713
- Conditions
- Breast Ductal Carcinoma In Situ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2019 (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.
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of multi-epitope HER2 peptide vaccine H2NVAC (H2NVAC) given for 4 treatments in patients with HER2-expressing ductal carcinoma in situ (DCIS) prior to surgery.
II. To determine the dose level of H2NVAC with maximum systemic and intratumoral immunogenicity as measured by activated HER2-specific T lymphocytes or high-affinity antibodies.
SECONDARY OBJECTIVES:
- To determine intratumoral immunogenicity of H2NVAC in patients with HER2-expressing DCIS.
II. To assess the complete pathological response after 4 treatments of neoadjuvant H2NVAC.
III. To assess the systemic immunogenicity of H2NVAC in patients with HER2-expressing DCIS.
IV. To assess changes in HER2 expression in the DCIS after 4 treatments of neoadjuvant H2NVAC.
- To assess the distribution of the helper T cell response among T helper cell differentiation states.
OUTLINE: This is a dose-escalation study of multi-epitope HER2 peptide vaccine H2NVAC followed by a dose expansion study for dose level.
Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive granulocyte macrophage-colony-stimulating factor (GM-CSF) admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo echocardiography (ECHO) and collection of blood samples throughout the trial and may undergo biopsy on trial.
After completion of study treatment, patients are followed up at 3, 6, and 12 months after surgery and optionally at 18 and 24 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) | Experimental | Biological: Granulocyte-Macrophage Colony-Stimulating Factor, Biological: Multi-epitope HER2 Peptide Vaccine H2NVAC, Procedure: Therapeutic Conventional Surgery, Procedure: Echocardiography Test, Procedure: Biospecimen Collection, Procedure: Biopsy ProcedurePrior to standard of care surgery, patients treated at dose levels 1 and 2 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo ECHO and collection of blood samples throughout the trial and may undergo biopsy on trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Patients must not have received any prior therapy for current DCIS
- Any degree of HER2 expression as performed on the diagnostic clinical biopsy defined by immunohistochemistry +1, +2, or +3
- Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis
- Patients will be asked to have an additional research biopsy prior to the first vaccination. This is not mandatory for participation
Key exclusion criteria (23 listed)
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids, unless physiologic replacement for adrenal or pituitary insufficiency
- 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
- Uncontrolled acute or chronic medical conditions including, but not limited to the following:
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 |
|---|---|---|
| Granulocyte-Macrophage Colony-Stimulating FactorAlso: Colony Stimulating Factor 2, Colony Stimulating Factor, Granulocyte-Macrophage, Colony-Stimulating Factor, Colony-Stimulating Factor 2Given intradermally | Biological | Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) |
| Multi-epitope HER2 Peptide Vaccine H2NVACAlso: H2NVAC, HER2 Peptide Vaccine H2NVAC, HER2 Specific Helper T-cell Epitope Vaccine H2NVACGiven intradermally | Biological | Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) |
| Therapeutic Conventional SurgeryUndergo standard of care surgery | Procedure or surgery | Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) |
| Echocardiography TestAlso: EC, ECHOCARDIOGRAPHY, ECHOUndergo ECHO | Procedure or surgery | Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) |
| Biopsy ProcedureAlso: BIOPSY, BIOPSY_TYPEUndergo biopsy | Procedure or surgery | Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF) |
Primary outcome
Adverse events
Time frame: 2 years
Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Dose limiting toxicities
Time frame: 14 days post vaccination, 2 years
Measured using criteria from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 with grade >= 3 allergic reaction, grade >= 3 autoimmune reaction (except for autoimmune encephalitis grade >=4), grade >= 3 injection site reaction manifesting as an ulceration, grade >= 3 neurologic problem, grade >= 3 non-hematologic or cardiac toxicity, or changes in left ventricular ejection fraction (LVEF) as specified per protocol.
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 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Amy C. Degnim, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Granulocyte-Macrophage Colony-Stimulating Factor, Multi-epitope HER2 Peptide Vaccine H2NVAC and Therapeutic Conventional Surgery in people with Breast Ductal Carcinoma In Situ, run by Mayo Clinic 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 23 inclusion and 23 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 Mar 2026. 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 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 2 years). 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 Mar 2026.