Is NCT04144023 recruiting in Rochester, MN?

Yes, NCT04144023 is currently recruiting participants at its Rochester, MN location. This breast ductal carcinoma in situ clinical trial is actively enrolling qualified participants.

How do I join the breast ductal carcinoma in situ clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Ductal Carcinoma In Situ Clinical Trial in Rochester, MN

About This Breast Ductal Carcinoma In Situ Study in Rochester

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.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT04144023) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Ductal Carcinoma In Situ Treatment Options in Rochester, MN

If you're searching for breast ductal carcinoma in situ treatment options in Rochester, MN, this clinical trial (NCT04144023) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast ductal carcinoma in situ specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast ductal carcinoma in situ clinical trials near you to find additional studies recruiting in your area.

Breast Ductal Carcinoma In Situ Clinical Trial in Rochester, MN

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