Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Hubei Cancer Hospital

Status

Enrolling

Conditions

Neoadjuvant Radiotherapy

Implant Breast Reconstruction

Breast Cancer

Treatments

Radiation: Neoadjuvant radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05992870

NeoRTIBR

Details and patient eligibility

About

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.

Full description

Radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results, including severe capsular contracture, mastectomy flap necrosis ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results and less complications compared to PMRT. Furthermore, some studies have shown that NART could potentially result in shorter time between diagnosis and treatment completion. 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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