Clinical trial · Interventional
Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
A Randomized Multicenter, Open, Prospective, Controlled Study-comparison of the Safety of Immediate One-stage Implant Based Breast Reconstruction(IBBR) Versus Two-stage Expander-Implant IBBR Augmented With TiLoop® Bra.
NCT03589924CI-TRIAL-00078109IBBRunknownN/AClinicalTrials.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)
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate-delayed IBBR+TiLoop®Bra | Procedure | — | UNRESOLVED |
| Immediate IBBR+TiLoop®Bra | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- One step method
- description
- Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
- interventionNames
- Procedure: Immediate IBBR+TiLoop®Bra
- type
- ACTIVE_COMPARATOR
- label
- Two step method
- description
- Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
- interventionNames
- Procedure: Immediate-delayed IBBR+TiLoop®Bra
Primary outcomes (1)
- measure
- Rate of perioperative complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological proven invasive breast cancer or ductal carcinoma in situ; * Clinical T1-T2 disease with no distant metastasis; * Patient with clinical N0 status; * Intent to receive NSM or SSM and implant based breast reconstruction; * Signed consent to participate. Exclusion Criteria: * Patient with severe breast ptosis; * Patient received ipsilateral breast reduction or enlargement; * Locally advanced stage patients who received neoadjuvant chemotherapy or hormone therapy; * Patients enrolled in other clinical trial which may as influence the outcome; * Patients received neo-adjuvant therapy and will receive radiotherapy. * History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast); * Patients of pregnancy or lactation.
References
Publications (1)
- DERIVEDChi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19. PMID 37216212