Clinical trial · Observational
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
NCT05866458CI-TRIAL-00124426ROSALIErecruitingClinicalTrials.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 de-escalate radiation therapy in women with breast cancer.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Single Arm Cohort
- description
- The study population consists of women with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, that have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (defined as absence of residual invasive and in situ breast cancer within the breast or lymph nodes).
Primary outcomes (1)
- measure
- Ipsilateral breast tumour recurrence (IBTR)
- timeFrame
- 5 years
- description
- defined as ipsilateral recurrence (invasive or insitu) in the ipsilateral breast or chest wall. Histological evidence of IBTR is required. All such events will be reviewed by a central adjudication committee.
Secondary outcomes (4)
- measure
- Mastectomy free interval
- timeFrame
- 5 years
- description
- defined as time from registration to undergoing ipsilateral mastectomy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type). 2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy. 3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy. 4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified. 5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection). 6. Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\]. Exclusion Criteria: 1. Age less than 50 years. 2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease). 3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast). 4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible. 5. Synchronous contralateral in-situ or invasive breast cancer. 6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer. 7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years. 8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment). 9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated. 10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy. 11. ECOG (Eastern Cooperative Oncology Group) performance status \> 3. 12. Inability to provide informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.