Clinical trial · Interventional
Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial
A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer
NCT04116125CI-TRIAL-00040996OBSERBunknownN/AClinicalTrials.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)
The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
Conditions
Conditions (2)
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 Neoplasm Female | — | UNRESOLVED | — |
| Lymphatic Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Sentinel lymph node biopsy
- description
- Perform conventional sentinel lymph biopsy
- interventionNames
- Procedure: Radiotherapy
- type
- EXPERIMENTAL
- label
- Adjuvant radiation without Sentinel lymph node biopsy
- description
- Perform radiotherapy instead of sentinel lymph node biopsy
- interventionNames
- Procedure: Radiotherapy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. women aged \> 20 years 2. cT1-3N1M0, primary invasive 3. initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy 4. completion of neoadjuvant chemotherapy 5. tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy Exclusion Criteria: 1. synchronous distant metastases 2. previous other malignancy 3. bilateral breast cancer 4. previous primary systemic therapy 5. pregnancy or breastfeeding 6. pre-operative radiological evidence of multiple involved or suspicious axillary nodes 7. patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.