Oncotype DX
Diagnostic TestAll patients received Oncotype DX test.
NCT Number: NCT07311122
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.
Trial opening soon.
Get Notified20 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A. History of menstruation within 6 months prior to diagnosis. B. Serum FSH < 30 mIU/mL. C. If criteria A or B are unavailable, women aged ≤50 years are considered premenopausal.
A. pN0: RS 11-25. B. pN1: RS ≤25.
Exclusion criteria
A. Prior bilateral oophorectomy before the breast cancer diagnosis (considered postmenopausal).
B. Prior unilateral oophorectomy alone is not considered postmenopausal (classified as premenopausal).
C. Bilateral oophorectomy performed after breast cancer surgery for therapeutic purposes is not an exclusion; such patients will be categorized as having received ovarian function suppression (OFS).
D. Serum FSH ≥ 30 mIU/mL.
All patients received Oncotype DX test.
Time frame: 5 years after breast cancer diagnosis
Gangnam Severance Hospital
Other
Comparison of Endocrine Therapy Plus Ovarian Function Suppression and Chemotherapy Based on 21-gene RS in Young Age (≤ 50) Women (CUSTOM): Multi-center Registry Study
Acronym: CUSTOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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