Clin2
NCT04144023Possibly a fitRecruiting

Vaccine before surgery for HER2-positive breast duct cancer in place

Breast Ductal Carcinoma In Situ

Treatments studied

Part of Cancer clinical trials.

This Phase 1 study tests a vaccine (H2NVAC) given before surgery to help the body fight HER2-expressing ductal carcinoma in situ (DCIS) that has not been removed yet. Because it’s early-stage, the main goal is to check safety and learn how the treatment may work.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
43 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must have DCIS that has not been surgically removed yet, and there should be no spread to lymph nodes or distant organs
  • Your DCIS must show HER2 activity on biopsy (HER2 score can be low or high: +1, +2, or +3)
  • You must be well enough for study visits (ECOG 0 to 2) and have no prior treatment for this DCIS
  • You must be able to stop certain hormone-blocking medicines before vaccination (endocrine therapy during the vaccine/surgery period is not allowed)
  • Your blood tests must be high enough (neutrophils, platelets, and hemoglobin) and your liver and kidney labs must be acceptable
  • If you could become pregnant, you must use reliable birth control through 6 months after the last vaccine dose

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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