Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Cancer; Neoadjuvant Radiotherapy; Implant Breast Reconstruction
• Interventions: Radiation: Neoadjuvant radiotherapy

• Registration Number: NCT05992870
• Lead Sponsor: Hubei Cancer Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-07-08
• Study First Submitted: 2023-08-05
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-15
• Status Verified: 2024-08
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-07-08
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant radiotherapy group	Neoadjuvant radiotherapy	Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH

Primary Outcome Measures

Name	Time	Method
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART	3 months following skin-sparing mastectomy and immediate breast reconstruction	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction.	3 months and 12 months after surgery	Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.
Number of participants with removal of implant.	6 months after surgery	Implant are removed for postoperative complications.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .	Within 3 months after both breast reconstruction and radiotherapy	Other adverse events following NART or surgery other than described in the primary outcome measure.
Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen	Within 2 weeks after skin-sparing mastectomy	A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).

Trial Locations

Locations (1)

Xinhong Wu; 🇨🇳 Wuhan, Hubei, China