Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)

This is an open label, phase II study evaluating the efficacy and safety of trastuzumab combined with oral chemotherapy or endocrine therapy in patients with HER-2 positive stage I breast cancer.

Trial Details

NCT ID
NCT04383275
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • capecitabine and trastuzumab
  • endocrine therapy and trastuzumab
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Females 18-70 years old;
  • Pathological confirmed of stage I breast cancer: histologically confirmed that the longest diameter of invasive cancer is no more than 2cm and the …
  • In IRIS-A cohort, if a patient is HR negative(ER/PR\<10%), the longest diameter of invasive cancer could not exceed 2cm; while if a patient is HR p…
  • In IRIS-B cohort, a patient need to be HR positive (ER and / or PR expression ≥10%) and the longest diameter of invasive cancer could not exceed 1cm;

For full eligibility, visit ClinicalTrials.gov.

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