Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

NCT05992870 | Recruiting

• 1 other identifier: NeoRTIBR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Implant Breast Reconstruction; Neoadjuvant Radiotherapy

Keywords

neoadjuvant radiotherapy, implant, breast reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .

  Within 3 months after both breast reconstruction and radiotherapy

• Number of participants with removal of implant.

  6 months after surgery

• Patient satisfaction.

  3 months and 12 months after surgery

• Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen

  Within 2 weeks after skin-sparing mastectomy

Study Arms (1)

Neoadjuvant radiotherapy group

EXPERIMENTAL

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

Radiation: Neoadjuvant radiotherapy

Interventions

Neoadjuvant radiotherapy RADIATION

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 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Xinhong Wu

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Xinhong Wu, MD

CONTACT

+8618602726300; 34053889@qq.com

Ning Zou, MD

CONTACT

+8615007162698; sunnyning116@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 15, 2023
• Study Start: July 8, 2023
• Primary Completion: July 8, 2025
• Study Completion: October 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)