Endocrine Therapy Base on 21-gene RS
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorGangnam Severance Hospital
About this trial
Among patients aged ≤50 years with hormone receptor-positive, HER2-negative breast cancer and pathologic nodal stage pN0-1-limited to those with an Oncotype DX® Recurrence Score (RS) of 11-25 for pN0 and ≤25 for pN1-, we will investigate the followings:
i) Real-world patterns of adjuvant therapy (systemic chemotherapy and endocrine therapy) and radiotherapy according to N stage and Oncotype DX® RS.
ii) Clinicopathologic characteristics of each patient subgroup by adjuvant treatment modality and RS category.
iii) Survival outcomes and independent prognostic factors according to RS. iv) Survival analyses by adjuvant treatment modality, stratified by RS category, clinical risk, and N stage.
Through these analyses, we aim to establish clinical evidence on whether endocrine therapy combined with ovarian function suppression (OFS) can substitute for adjuvant chemotherapy in HR+/HER2- patients with pN0-1 disease within the above RS ranges, and-if so-to define the patient subsets for whom this substitution is appropriate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed breast cancer.
Age ≤50 years at initial diagnosis.
Underwent curative-intent breast cancer surgery between January 2012 and December 2021.
Pathologic tumor stage pT1-pT3 after surgery.
Disqualifiers
Evidence of distant (systemic) metastasis at diagnosis.
Hormone receptor-negative or HER2-positive disease.
Insufficient or unclear data regarding the type of adjuvant therapy received.
History of another malignancy treated before the breast cancer diagnosis, except for thyroid cancer and non-melanoma skin cancer.
Trial population
This study included the patients aged ≤ 50 years with hormone receptor-positive, HER2-negative breast cancer and pathologic nodal stage pN0-1 and those with an Oncotype DX® Recurrence Score (RS) of 11-25 for pN0 and ≤25 for pN1.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Oncotype DX
Diagnostic testAll patients received Oncotype DX test.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
invasive disease-free survival
Time frame
5 years after breast cancer diagnosisLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: