Last reviewed · How we verify
NCT07311122: CUSTOM
Endocrine Therapy Base on 21-gene RS
trial testing Oncotype DX in Breast Cancer in 4,000 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Gangnam Severance Hospital |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 4,000 |
| Start date | 1 January 2026 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
Drugs / interventions tested
- Oncotype DX
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Gangnam Severance Hospital
Who can join
20 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07311122
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07311122 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gangnam Severance Hospital
- Last refreshed: 30 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07311122.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing