Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Implant Breast Reconstruction; Neoadjuvant Radiotherapy
• Intervention / Treatment: Radiation: Neoadjuvant radiotherapy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinhong Wu, MD; Phone Number: +8618602726300; Email: 34053889@qq.com
• Study Contact Backup: Name: Ning Zou, MD; Phone Number: +8615007162698; Email: sunnyning116@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Xinhong Wu
      • Contact: Xinhong Wu, MD; Phone Number: +8618602726300; Email: 34053889@qq.com
      • Contact: Ning Zou, MD; Phone Number: +8615007162698; Email: sunnyning116@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant radiotherapy group; Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH	Radiation: Neoadjuvant radiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART	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.	3 months following skin-sparing mastectomy and immediate breast reconstruction

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hubei Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2023
• Primary Completion (Estimated): July 8, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: August 5, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: neoadjuvant radiotherapy, implant, breast reconstruction
• Other Study ID Numbers: NeoRTIBR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No