Clinical trial · Observational
Adjuvant Treatment in Premenopausal Breast Cancer
PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test
NCT06807749CI-TRIAL-00125751PERSEVEREXrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- node negative (pN0)
- description
- Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test
- label
- node positive (pN1)
- description
- Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test
Primary outcomes (1)
- measure
- Invasive Disease-Free Survival (iDFS) at 5 years
- timeFrame
- up to 30 months
- description
- The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.
Secondary outcomes (1)
- measure
- To describe the effect of the different adjuvant treatments according to clinical and genomic risk
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, premenopausal and ≥18 years age patients. 2. Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable 3. Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative. 4. Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3. 5. Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND). 6. Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022 7. Availability of clinical and pathological information. 8. Availability of information about adjuvant treatment received. 9. Availability of patient' outcome information (relapse, site of relapse, survival). Exclusion Criteria: 1. Evidence of distant metastases 2. Inflammatory breast cancer 3. Neoadjuvant treatment 4. No surgery for primary breast cancer and axillary staging 5. Patients not tested with 21-multigene assay Oncotype DX
References
Publications (0)
Data not yet available
No reference posted for this study.