Clinical trial · Interventional
Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer
Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs
- 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 goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation. At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).
Conditions
Conditions (7)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Breast Tumors | Breast Neoplasm | ALIAS | 0.90 |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
| Human Mammary Carcinoma | — | UNRESOLVED | — |
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Removal of tumor and tissue | Procedure | — | UNRESOLVED |
| Remove tumor only | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Breast Conserving Surgery (BCS)
- interventionNames
- Procedure: Remove tumor only
- type
- ACTIVE_COMPARATOR
- label
- Breast Conserving Surgery with Additional 5 Margins (BCS + M)
- interventionNames
- Procedure: Removal of tumor and tissue
Primary outcomes (1)
- measure
- Comparing 2 surgical methods for treatment of early stage breast cancer
- timeFrame
- Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.
- description
- The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital * Age: no limit Exclusion Criteria: * Stage IV breast cancers
References
Publications (0)
Data not yet available