Clinical trial · Observational
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features
NCT04797299CI-TRIAL-00122172ELISArecruitingClinicalTrials.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)
To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)
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 |
|---|---|---|---|
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Single Arm Cohort
- description
- Evaluating the risk of Local Recurrence (LR) in a group of women postulated to be at low risk of LR following Breast Conserving Surgery alone defined by a combination of clinicopathological factors and Oncotype DX DCIS score.
Primary outcomes (1)
- measure
- Ipsilateral local recurrence (LR)
- timeFrame
- 5 Year
- description
- Defined as recurrent invasive or in situ cancer in the ipsilateral breast
Secondary outcomes (5)
- measure
- Ipsilateral invasive local recurrence
- timeFrame
- 5 Year
- description
- defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 46 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patient \> 45 years of age with DCIS without microinvasion. 2. Tumour size ≤ 2.5cm. 3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\* \* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins. 4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%. Exclusion Criteria: 1. Multifocal DCIS. 2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast. 3. Synchronous or previous invasive or non-invasive breast cancer. 4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers. 5. ECOG performance status ≥3. 6. Life expectancy \<10 years. 7. Geographic inaccessibility for follow-up.
References
Publications (0)
Data not yet available
No reference posted for this study.