Clin2
NCT04383275Possibly a fitActive, not recruiting

De-escalation trial for early HER2+ breast cancer

Breast Cancer

Part of Cancer, Skin clinical trials.

This Phase 2 study tests whether people with early-stage HER2-positive breast cancer may be treated with less intensive therapy, without losing effectiveness. You may be considered if your tumor is small, lymph nodes are negative, and your hormone (ER/PR) status and HER2 test results match the study groups.

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

Phase
Phase 2
Enrollment
367 people
Ages
18 years to 70 years
Study type
Interventional

Who can take part

  • You’re a woman age 18–70
  • Your breast cancer is stage I: tumor is 2 cm or less and lymph nodes are negative (N0)
  • Your tumor must be HER2-positive on testing: HER2 3+ OR HER2 0–2+ with a FISH test showing amplification
  • Your ER/PR (hormone) test results and tumor size must match one of the study groups (IRIS-A or IRIS-B)
  • Your heart and organs must work well (including LVEF above 50%) and blood counts are within limits
  • You have not had prior breast-cancer treatment (chemo/targeted/radiation/endocrine), and you are not pregnant or breastfeeding

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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