Is NCT04521764 recruiting in Rochester, MN?

Yes, NCT04521764 is currently recruiting participants at its Rochester, MN location. This anatomic stage iv breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

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.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Rochester, MN

Q: How do I join the anatomic stage iv breast cancer ajcc v8 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.

About This Anatomic Stage IV Breast Cancer AJCC v8 Study in Rochester

This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid \[DNA\]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years

COHORT 1 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR) /HER2 status and radiographic evidence of distant metastatic disease

COHORTS 2 \& 3 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic or recurrent disease

COHORT 1 ONLY: Radiographic evidence of distant metastatic disease (using 7th edition American Joint Committee on Cancer \[AJCC\] criteria) with two discrete sites of measurable disease

COHORTS 2 \& 3 ONLY: Radiographic evidence of distant metastatic or recurrent disease (using 8th edition AJCC criteria) with at least one site of measurable disease

Prior therapies:

Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy or combination of endocrine therapy with other agents such as CDK4/6 inhibitors

Patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for HER2 directed therapy with trastuzumab or pertuzumab

Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease

COHORT 1: At least one site of recurrent/metastatic disease that measures \> 1 cm in greatest dimension (\> 2 cm for lung lesions) and is amenable to safe percutaneous intratumoral administration of MV-s-NAP as determined by an interventional radiologist

COHORTS 2 \& 3 ONLY: At least 1 site of recurrent/metastatic disease measuring \> 1 cm in greatest dimension \[\> 2 cm for lung lesions\] (Note that if the lesion injected in cycle 1 is not amenable to re-injection, another lesion could be selected for injection

Absolute neutrophil count (ANC) \>= 1500/uL (=\< 7 days prior to registration)

Platelets (PLT \>= 100,000/uL) (=\< 7 days prior to registration)

Total bilirubin =\< institutional upper limit of normal (=\< 7 days prior to registration)

Aspartate aminotransferase (AST) =\< 2 x upper limit of normal (ULN) (=\< 7 days prior to registration)

Creatinine =\< 1.5 x ULN (=\< 7 days prior to registration)

Hemoglobin \>= 9.0 g/dL (=\< 7 days prior to registration)

Negative pregnancy test done =\< 7 days prior to registration (for women of childbearing potential only)

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Ability to provide informed written consent

Willingness to return to the Mayo Clinic enrolling institution for follow-up

Willingness to provide biologic samples for correlative research purposes

Life expectancy \>= 12 weeks

Concomitant administration of a bone modifying agent (e.g., zoledronic acid or denosumab) is permitted for the prevention or management of skeletal related events in patients with bone metastases and documentation of tolerability with prior exposures

Exclusion Criteria

Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy

Clinical or radiographic suspicion of impending visceral crisis due to invasion or compression by tumor

Active infection =\< 5 days prior to registration

History of other malignancy =\< 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix

Any of the following prior therapies:

Chemotherapy =\< 3 weeks prior to registration

Immunotherapy =\< 4 weeks prior to registration

HER2 directed therapy =\< 3 weeks prior to registration

Targeted therapy =\< 2 weeks prior to registration (e.g., CDK4/6 inhibitors, everolimus)

Investigational agent =\< 4 weeks prior to registration

Any viral or gene therapy prior to registration

Failure to fully recover from acute, reversible effects of prior systemic therapy regardless of interval since last treatment

New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \[SVT\])

Untreated or progressive central nervous system (CNS) metastases

NOTE: Patients with a history of treated brain metastases (surgical resection, whole brain radiation, and/or stereotactic radiosurgery) are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including \< 28 days of study entry

Standing requirement for blood product support

Human immunodeficiency virus (HIV) positive test result or history of other immunodeficiency

History of organ transplantation

History of chronic hepatitis B or C

Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)

Any concurrent medications that the principal investigator determines could interfere with the trial

Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids

Exposure to household contacts =\< 15 months old or household contact with known immunodeficiency

Allergy to measles vaccine or history of severe reaction to prior measles vaccination

History of receiving the measles vaccination with the "killed vaccine" between 1963-1967 without subsequent re-immunization (2 doses) with the active, live vaccination."

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 (NCT04521764) 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.

Anatomic Stage IV Breast Cancer AJCC v8 Treatment Options in Rochester, MN

If you're searching for anatomic stage iv breast cancer ajcc v8 treatment options in Rochester, MN, this clinical trial (NCT04521764) 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 anatomic stage iv breast cancer ajcc v8 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 anatomic stage iv breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Rochester, MN

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