Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
Recruiting
Phase 2
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 356 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
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 Locations
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Eligibility Criteria
Inclusion 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 lymph node is negative (N0);
* In IRIS-A cohort, if a patient is HR negative(ER/PR\<10%), the longest d…
Contacts