OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Recruiting
Phase 4
Interventional Study
Breast Cancer
Estrogen Receptor Positive Tumor
HER2-negative Breast Cancer
Premenopausal Breast Cancer
Node-positive 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
- 20 – 50
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 418 (estimated)
- Sponsor
- Gangnam Severance Hospital · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®). In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* ER+HER2- breast cancer
* Premenopausal and age \<=50
* T1 or T2
* N1 including micrometastasis
* Genomic Low Risk by OncoFREE test® (1-20)
Exclusion Criteria:
* Postmenopausal women
* ER-negative breast cancer
Contacts