Measles virus turned against breast cancer tumors
NCT ID NCT04521764
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This early-phase trial is testing a modified measles virus (MV-s-NAP) that is injected directly into tumors in people with metastatic breast cancer. The virus is designed to kill cancer cells and also carry an extra protein to boost the immune response. Researchers are monitoring up to 54 participants to find the safest dose and see if the virus can shrink both injected and non-injected tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- modified measles virus (MV-s-NAP)
- What this could lead to
- If it works, this could point toward a new way to treat metastatic breast cancer by using a virus to attack tumors and boost the immune system.
- What could go wrong
- This is a very early phase I trial with only 54 people, so it is not yet known if the virus is safe or effective. The virus may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 or low dose systemic steroids for physiologic replacement (e.g., Prednisone ≤10 mg/day) * 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."
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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