HER2/Neu NegativePhase 1WOKVACNCT02780401

Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

A Phase 1 study testing Laboratory Biomarker Analysis, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine and Sargramostim in people with HER2/Neu Negative and No Evidence of Disease, run by University of Washington at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes
What is being tested?: Laboratory Biomarker Analysis, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine and Sargramostim
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: 2 Sep 2016to 8 Oct 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as
0-1+ HER2 expression by immunohistochemistry (IHC) OR
Fluorescence in situ hybridization (FISH) negative OR
HER2 2+ and FISH negative
Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy administered during the study are eligible and may continue throughout duration of study
Patients must be at least 28 days post systemic steroids prior to enrollment

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Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
White blood cell (WBC) >= 3000/mm^3
Hemoglobin (Hgb) >= 10 g/dl
Lymphocyte count >= 800/mm^3
Platelet count >= 75,000/mm^3
Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
Total bilirubin =< 1.5 mg/dl
Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) =< 2 times upper limit of normal (ULN)
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
The effects of WOKVAC on the developing human fetus are unknown. For this reason, patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) for the duration of study participation; should a woman become pregnant while participating in the study, she should inform her study doctor immediately and will not receive any more study treatment
Left ventricular ejection fraction (LVEF) results must be >= lower limit of normal (LLN) for institution performing based on results from the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done at baseline
Willing to not undergo any elective surgical procedure with general anesthesia or conscious sedation through the 1 month post-vaccination visit
Ability to understand and the willingness to sign a written informed consent document

Who cannot join

Patients with any of the following cardiac conditions:
Symptomatic restrictive cardiomyopathy
Dilated cardiomyopathy
Unstable angina within 4 months prior to enrollment
New York Heart Association functional class III-IV heart failure on active treatment
Symptomatic pericardial effusion

Show all 13Show fewer

Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to WOKVAC
Patients with any contraindication or known hypersensitivity to receiving sargramostim (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
Pregnant women are excluded from this study because WOKVAC is a vaccine agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WOKVAC breastfeeding should be discontinued if the mother is treated with this vaccine
History of diabetes
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
History of autoimmunity that has not been controlled with treatment in the last 12 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients With Breast Cancer

This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.

Read the detailed description

OUTLINE: This is a dose escalation study of WOKVAC.

Patients receive WOKVAC with sargramostim intradermally (ID) on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients with axillary lymph node dissection (ALND) will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.

After completion of study treatment, patients are followed up at 1 month, 6 months and annually for up to 5 years thereafter.

Conditions: HER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer
Being tested: Laboratory Biomarker Analysis, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Sargramostim
Keywords: Stage I, Stage II, Stage III
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laboratory Biomarker AnalysisOther
Correlative studies
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA VaccineBiological
Also called pUMVC3-IGFBP2-HER2-IGF1R, pUMVC3-IGFBP2-HER2-IGF1R Vaccine, WOKVAC, WOKVAC Vaccine
Given ID
SargramostimBiological
Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine
Given ID

Study groups in NCT02780401
Study group	Role	What they receive
Treatment (WOKVAC with sargramostim)	Experimental	Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. Receives: Other: Laboratory Biomarker Analysis; Biological: pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine; Biological: Sargramostim

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0
Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine.
Measured: Up to 9 months

Secondary outcomes (6)

Assessment of IgG Antibodies
Immune response will be measured by indirect enzyme-linked immunosorbent assay and serum antibody avidity to determine an avidity index before and after vaccination. Patients will be considered to have developed an antibody response if antigen specific IgG antibodies are both detectable and have moderate to high avidity.
Measured: Up to 4 months
Assessment of T Helper Th1:Th2 Ratio
IFN-g (Th1) and IL-10 (Th2) T-cells will be evaluated using enzyme-linked immunosorbent spot assay. Patients will be considered to have developed a Th1 immune response as the sum IFN-Ɣ magnitude from all antigens to maximum response. This will be presented as a median fold change from baseline to the maximum response (1 or 6 months after vaccination).
Measured: Up to 9 months
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
Immune responses will be measured by IFN-g enzyme-linked immunosorbent spot assay using blood (PBMC) represented by a maximum immune response generated to each antigen individually measured as corrected spots per well (cSPW). At the immune evaluations, each patient was given a value to indicate their immune response at both baseline and post vaccination. This data is represented by a median response, at both baseline (before vaccination) and 1 month or 6 months after the last vaccination of 3 vaccines (maximum response), to each of the 3 vaccine antigens HER2, IGFBP-2 or IGF1R.
Measured: Up to 24 weeks
Level of Antigen Specific Central and Effector Memory Phenotypes (Persistent Memory T Cell Response)
Assessed by flow cytometry of peripheral blood mononuclear cells using an established T-cell activation panel and summarized with mean and standard deviation or median and range over time.
Measured: Up to 6 months after the last vaccine
Modulation of Myeloid Derived Suppressor Cell Levels
Assessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with mean and standard deviation or median and range over time.
Measured: Up to 24 weeks
Modulation of T Regulatory Cell Levels
Assessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with median and range. FOXP3 is used to identify regulatory T cells, specifically CD4+ cells isolated from PBMC.
Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 20168 Oct 2022

First posted23 May 2016 (estimated)
Study start2 Sep 2016
Primary completion8 Oct 2020
Study completion8 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HER2/Neu NegativeStudies of the same condition, open and under way.
More trials run by University of WashingtonThe 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02780401
Sponsor's protocol ID: 9626
Other IDs: NCI-2016-00581, UW14090, N01-CN-2012-00033, UWI4090, UWI2014-03-01, N01CN00033, P30CA014520, RG1716053
Acronym: WOKVAC
Status last verified: Aug 2024
First submitted: 27 Apr 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The original intent of this study did not define a plan to make IPD available. We will follow the NCI policy.

Publications

Disis ML, Gad E, Herendeen DR, Lai VP, Park KH, Cecil DL, O'Meara MM, Treuting PM, Lubet RA. A multiantigen vaccine targeting neu, IGFBP-2, and IGF-IR prevents tumor progression in mice with preinvasive breast disease. Cancer Prev Res (Phila). 2013 Dec;6(12):1273-82. doi: 10.1158/1940-6207.CAPR-13-0182. Epub 2013 Oct 23.
PubMed 24154719
Stanton SE, Cecil DL, Bailey HH, Liu Y, Gwin WR, Colveler AL, Liao JB, Wisinski KB, Barroilhet L, Kim K, Havighurst TC, DeShong K, Twaroski K, Childs JS, Dimond E, Wojtowicz M, Heckman-Stoddard BM, Disis ML. Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer. J Immunother Cancer. 2026 May 4;14(5):e014314. doi: 10.1136/jitc-2025-014314.
PubMed 42082270

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
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NSCLC, SCLC
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer

All HER2/Neu Negative trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients With Breast Cancer
ClinicalTrials.gov ID: NCT02780401
Acronym / sponsor ID: WOKVAC / 9626
Conditions: HER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer
Keywords: Stage I, Stage II, Stage III
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), University of Wisconsin, Madison
Study start: 2 Sep 2016 (actual)
Primary completion: 8 Oct 2020 (actual)
Study completion: 8 Oct 2022 (actual)
First posted: 23 May 2016 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OUTLINE: This is a dose escalation study of WOKVAC.

Patients receive WOKVAC with sargramostim intradermally (ID) on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, 6 months and annually for up to 5 years thereafter.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (WOKVAC with sargramostim)	Experimental	Other: Laboratory Biomarker Analysis, Biological: pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Biological: SargramostimPatients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as
Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy administered during the study are eligible and may continue throughout duration of study
Patients must be at least 28 days post systemic steroids prior to enrollment
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
White blood cell (WBC) >= 3000/mm^3

Key exclusion criteria (13 listed)

Patients with any of the following cardiac conditions:
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to WOKVAC
Patients with any contraindication or known hypersensitivity to receiving sargramostim (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
Pregnant women are excluded from this study because WOKVAC is a vaccine agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WOKVAC breastfeeding should be discontinued if the mother is treated with this vaccine

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
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (WOKVAC with sargramostim)
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA VaccineAlso: pUMVC3-IGFBP2-HER2-IGF1R, pUMVC3-IGFBP2-HER2-IGF1R Vaccine, WOKVAC, WOKVAC VaccineGiven ID	Biological	Treatment (WOKVAC with sargramostim)
SargramostimAlso: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, ProkineGiven ID	Biological	Treatment (WOKVAC with sargramostim)

Primary outcome

Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 9 months
Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine.

6 secondary outcomes

Assessment of IgG Antibodies
Time frame: Up to 4 months
Assessment of T Helper Th1:Th2 Ratio
Time frame: Up to 9 months
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
Time frame: Up to 24 weeks
Level of Antigen Specific Central and Effector Memory Phenotypes (Persistent Memory T Cell Response)
Time frame: Up to 6 months after the last vaccine
Modulation of Myeloid Derived Suppressor Cell Levels
Time frame: Up to 24 weeks
Modulation of T Regulatory Cell Levels
Time frame: Up to 24 weeks

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim	10	10
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim	12	10
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim	10	10

Primary outcome: Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0

Time frame: Up to 9 months. Number. Unit: Count of Related Adverse Events per Arm

Measure	Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim n = 10	Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim n = 12	Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim n = 10
Grade 1 related adverse events	45	53	30
Grade 2 related adverse events	2	1	7

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim	0 of 12 (0%)	12 of 12 (100%)	1 of 12
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim	0 of 10 (0%)	10 of 10 (100%)	1 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24154719Disis ML, Gad E, Herendeen DR, Lai VP, Park KH, Cecil DL, O'Meara MM, Treuting PM, Lubet RA. A multiantigen vaccine targeting neu, IGFBP-2, and IGF-IR prevents tumor progression in mice with preinvasive breast disease. Cancer Prev Res (Phila). 2013 Dec;6(12):1273-82. doi: 10.1158/1940-6207.CAPR-13-0182. Epub 2013 Oct 23.
Derived from this study: PubMed 42082270Stanton SE, Cecil DL, Bailey HH, Liu Y, Gwin WR, Colveler AL, Liao JB, Wisinski KB, Barroilhet L, Kim K, Havighurst TC, DeShong K, Twaroski K, Childs JS, Dimond E, Wojtowicz M, Heckman-Stoddard BM, Disis ML. Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer. J Immunother Cancer. 2026 May 4;14(5):e014314. doi: 10.1136/jitc-2025-014314.
Individual participant dataSharing planned: No. The original intent of this study did not define a plan to make IPD available. We will follow the NCI policy.

Related trials for HER2/Neu Negative

RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
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Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer

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.

Kari Wisinski principal investigator

University of Wisconsin, Madison

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02780401, which also lists 2 linked publications.

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 19 Sep 2024.