Clinical trial · Observational
Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
A Multi-center Prospective Observational Trial Investigating the Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
- 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 purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delayed Breast Reconstruction | Procedure | — | UNRESOLVED |
| Immediate Breast reconstruction | Procedure | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- BR group
- description
- Breast reconstruction without radiation therapy
- interventionNames
- Procedure: Immediate Breast reconstruction
- Procedure: Delayed Breast Reconstruction
- label
- Immediate BR +post-op radiation
- description
- Immediate breast reconstruction followed by surgical site radiation therapy
- interventionNames
- Procedure: Immediate Breast reconstruction
- Radiation: Radiation
- label
- Radiation +delayed BR
- description
- previous post-mastectomy radiation followed by delayed breast reconstruction
- interventionNames
- Procedure: Delayed Breast Reconstruction
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with breast cancer * Karnofsky Performance Status (KPS) larger than 70 * Underwent autologous or prosthetic based breast reconstruction * No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function. Exclusion Criteria: * Metastatic breast cancer * Local recurrence after mastectomy * Prior radiation history to chest wall due to other tumors * Radiation performed more than 6 months after mastectomy * Interruption of radiation more than 2 weeks * Gravida or during lactation * Concurrently undergoing psychotic disorders
References
Publications (14)
- BACKGROUNDSchaverien MV, Macmillan RD, McCulley SJ. Is immediate autologous breast reconstruction with postoperative radiotherapy good practice?: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1637-51. doi: 10.1016/j.bjps.2013.06.059. Epub 2013 Jul 22. PMID 23886555
- BACKGROUNDBerbers J, van Baardwijk A, Houben R, Heuts E, Smidt M, Keymeulen K, Bessems M, Tuinder S, Boersma LJ. 'Reconstruction: before or after postmastectomy radiotherapy?' A systematic review of the literature. Eur J Cancer. 2014 Nov;50(16):2752-62. doi: 10.1016/j.ejca.2014.07.023. Epub 2014 Aug 26. PMID 25168640
- BACKGROUNDBarry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20. PMID 21336948
- BACKGROUNDKelley BP, Ahmed R, Kidwell KM, Kozlow JH, Chung KC, Momoh AO. A systematic review of morbidity associated with autologous breast reconstruction before and after exposure to radiotherapy: are current practices ideal? Ann Surg Oncol. 2014 May;21(5):1732-8. doi: 10.1245/s10434-014-3494-z. Epub 2014 Jan 29. PMID 24473643
- BACKGROUNDLosken A, Nicholas CS, Pinell XA, Carlson GW. Outcomes evaluation following bilateral breast reconstruction using latissimus dorsi myocutaneous flaps. Ann Plast Surg. 2010 Jul;65(1):17-22. doi: 10.1097/SAP.0b013e3181bda349. PMID 20548235
- BACKGROUNDSelber JC, Kurichi JE, Vega SJ, Sonnad SS, Serletti JM. Risk factors and complications in free TRAM flap breast reconstruction. Ann Plast Surg. 2006 May;56(5):492-7. doi: 10.1097/01.sap.0000210180.72721.4a. PMID 16641623
- BACKGROUNDChang EI, Liu TS, Festekjian JH, Da Lio AL, Crisera CA. Effects of radiation therapy for breast cancer based on type of free flap reconstruction. Plast Reconstr Surg. 2013 Jan;131(1):1e-8e. doi: 10.1097/PRS.0b013e3182729d33.