Clinical trial · Interventional
Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
Surgical Resection Margin According to the Post-treatment Tumor Volume Versus the Pre-treatment Tumor Volume in Breast Conservative Surgery for Invasive Breast Cancer Patients Receiving Primary Systemic Therapy: Randomized Controlled 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)
Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. This trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bracketing | Procedure | — | UNRESOLVED |
| Neoadjuvant therapy | Drug | — | UNRESOLVED |
| Post-treatment volume margin resection | Procedure | — | UNRESOLVED |
| Pre-treatment volume margin resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Post-treatment volume-resection margin
- description
- Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor.
- interventionNames
- Procedure: Bracketing
- Drug: Neoadjuvant therapy
- Procedure: Post-treatment volume margin resection
- type
- ACTIVE_COMPARATOR
- label
- Pre-treatment volume-resection margin
- description
- Lumpectomy is performed with resection margin of the bracketed tissue.
- interventionNames
- Procedure: Bracketing
- Drug: Neoadjuvant therapy
- Procedure: Pre-treatment volume margin resection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven diagnosis of invasive adenocarcinoma of the breast. * Tumor stage T 1-4b * Nodal stage N 0-2 * ASA (American Society of Anesthesiologists) class I-II Exclusion Criteria: * Patients opting for mastectomy. * Patients advised for mastectomy by the treating physician. * Patients opting for primary surgical treatment. * Patients advised for primary surgical treatment by the treating physician. * Metastatic patients. * Multifocal tumors. * Lobular neoplasia. * Current pregnancy or pregnancy less than 6 months from the enrollment date. * Active second cancer.
References
Publications (2)
- BACKGROUNDZhou X, Li Y. Local Recurrence after Breast-Conserving Surgery and Mastectomy Following Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer - a Meta-Analysis. Breast Care (Basel). 2016 Oct;11(5):345-351. doi: 10.1159/000450626. Epub 2016 Oct 14. PMID 27920628
- BACKGROUNDGnant M, Harbeck N, Thomssen C. St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment. Breast Care (Basel). 2017 May;12(2):102-107. doi: 10.1159/000475698. Epub 2017 Apr 26. PMID 28559767