New vaccine aims to fight breast cancer by training the immune system
NCT ID NCT04270149
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a vaccine made from estrogen receptor peptides, combined with immune boosters, in 8 people with ER-positive breast cancer who have completed standard therapy. The goal is to see if the vaccine is safe and can trigger an immune response against cancer cells. It may help prevent recurrence in patients with higher-risk disease.
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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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8 people
The number who actually took part.
- 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: * Patients with histologically confirmed, resected, breast cancer with one of the following characteristics: pT3 or greater T stage with any N stage and M0 pTxN+M0 (i.e., N1,2 or 3) * HLA A0201+ and tumor is ER+ * Patients must have completed any standard chemotherapy recommended by their physician. There must be at least 4 weeks from their last dose of chemotherapy (or surgery if no chemotherapy was given) prior to the first dose of study vaccine. There should be no more than 5 years from the time of completion of any chemotherapy, surgery or HER2 targeted therapy. Ongoing endocrine therapies are permitted as long as they have been administered for at least 3 months prior to study enrollment. * Age ≥ 18 years. * Heme: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, platelets ≥ 80,000/microliter. * Adequate, renal and hepatic function with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except a bilirubin of \<2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT \< 2 x upper limit of normal. * Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines. Exclusion Criteria: * Subjects with concurrent chemotherapy, radiation therapy, or immunotherapy are excluded. There must be at least 4 weeks between these prior therapy and study treatment. Subjects must have recovered from all acute toxicities from prior treatment. Peripheral neuropathy grade 1 due to prior therapy will be permitted. * Subjects may not have history of distant metastases. * Subjects with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. A positive ANA (anti-nuclear antibody) test without other evidence of autoimmune disease will not exclude a subject for this study. A prior history of autoimmune hypothyroidism will not exclude a subject. * Subjects with serious intercurrent chronic or acute illness, such as cardiac disease, (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment. * Subjects with a medical or psychological impediment to probable compliance with the * Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer. * Presence of an active acute or chronic infection including: an urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Subjects with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; subjects with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. * Subjects on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Subjects must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment. * Subjects with allergies to any component of the vaccine * Pregnant or nursing mothers. * Subjects with acute or chronic skin disorders that will interfere with peptide injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded. * Splenectomy
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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.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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