Neoplasms

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Breast Neoplasms

Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH

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.

Neoadjuvant radiotherapy

Xinhong Wu, MD

Ning Zou, MD

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.

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.

Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.

Other adverse events following NART or surgery other than described in the primary outcome measure.

Implant are removed for postoperative complications.

Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.

A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction	NCT05992870	Breast Cancer Implant Breast ... Neoadjuvant Rad...	Neoadjuvant rad...	18 Years - 75 Years	Hubei Cancer Hospital
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction	NCT05992870	Breast Cancer Implant Breast ... Neoadjuvant Rad...	Neoadjuvant rad...	18 Years - 75 Years	Hubei Cancer Hospital
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction	NCT05992870	Breast Cancer Implant Breast ... Neoadjuvant Rad...	Neoadjuvant rad...	18 Years - 75 Years	Hubei Cancer Hospital

Spots Global Cancer Trial Database for neoadjuvant radiotherapy, implant, breast reconstruction