Clinical trial · Interventional
Delayed-Immediate Breast Reconstruction
NCT00473122CI-TRIAL-00023098completedPhase 2ClinicalTrials.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)
The goal of this clinical research study is to evaluate a new two-stage approach (delayed-immediate reconstruction) to breast reconstruction in women who may require post-mastectomy radiation therapy. Researchers will compare the cosmetic outcomes and any complications that occur in women who receive delayed-immediate reconstruction to those who receive the standard approaches (either immediate reconstruction or delayed breast reconstruction).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delayed-Immediate Breast Reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Delayed-Immediate Breast Reconstruction
- description
- Delayed-Immediate Reconstruction: If radiation therapy (XRT) not needed, immediate reconstruction. If XRT is needed, delayed reconstruction until XRT complete.
- interventionNames
- Procedure: Delayed-Immediate Breast Reconstruction
Primary outcomes (1)
- measure
- Efficacy of Delayed-Immediate Breast Reconstruction
- timeFrame
- 5 Years
- description
- Patient data and photographs gathered throughout the various stages of delayed-immediate reconstruction, during routine preoperative, intraoperative, and postoperative examinations. Details of primary disease include preoperative tumor stage, method of breast cancer diagnosis, tumor biologic characteristics, and the use of neoadjuvant chemotherapy. Preoperative and postoperative tumor stage compared to evaluate the indications for the delayed-immediate approach to breast reconstruction.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients with clinical stage I or stage II breast cancer who may require postmastectomy XRT. 2. Patients will be required to receive postmastectomy XRT as well as breast reconstructive procedures, including subsequent deflation and re-inflation of the prosthesis after XRT at University of Texas MD Anderson Cancer Center (UT MDACC). 3. Patients must sign the consent form and must be able to withstand two (2) anesthetic procedures. 4. Patients with stage I breast cancer who will be eligible for delayed-immediate breast reconstruction will have extensive microcalcifications within the affected by mammography that make it difficult to determine preoperatively the extent of invasive disease. Exclusion Criteria: 1. Patients with stage III or stage IV breast cancer who are known preoperatively to require postmastectomy XRT. 2. Patients with stage I breast cancer who are unlikely to require postmastectomy XRT.
References
Publications (0)
Data not yet available
No reference posted for this study.