Clinical trial · Interventional
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial
- 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)
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast. Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy. In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response. There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
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 |
|---|---|---|---|
| Inflammatory Breast Cancer | Breast Inflammatory Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast conserving surgery | Procedure | — | UNRESOLVED |
| Radical modified mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast conserving surgery
- interventionNames
- Procedure: Breast conserving surgery
- type
- ACTIVE_COMPARATOR
- label
- Radical modified mastectomy
- interventionNames
- Procedure: Radical modified mastectomy
Primary outcomes (1)
- measure
- local recurrence rate
- timeFrame
- 24 months
- description
- Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with inflammatory breast cancer * Clinical complete response after neoadjuvant chemiotherapy * Targeted tumor * Written informed consent Exclusion Criteria: * Metastasis * Progression disease * Recurrent disease * Contraindications to adjuvant radiation therapy
References
Publications (0)
Data not yet available