Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

March 14, 2025 updated by: Xinhong Wu, PhD, Hubei Cancer Hospital
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Xinhong Wu
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
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 .
Time Frame: Within 3 months after both breast reconstruction and radiotherapy
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.
Time Frame: 6 months after surgery
Implant are removed for postoperative complications.
6 months after surgery
Patient satisfaction.
Time Frame: 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.
3 months and 12 months after surgery
Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen
Time Frame: 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).
Within 2 weeks after skin-sparing mastectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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