Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Hubei Cancer Hospital
40 participants
Jul 8, 2023
INTERVENTIONAL
Conditions
Summary
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
Eligibility
Inclusion Criteria4
- Women \>18 years with histopathologically-confirmed breast cancer, who:
- require mastectomy for any reason
- a known indication for (adjuvant) radiotherapy
- require implant-based breast reconstruction
Exclusion Criteria5
- Inability to give informed consent
- MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings
- Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla
- Pregnant or lactating
- inflammatory breast cancer
Interventions
In case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week. A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05992870