Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992870
• Other study ID #: NeoRTIBR
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: Hubei Cancer Hospital
• Contact: Xinhong Wu, MD
• Phone: +8618602726300
• Email: 34053889[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2025
• Est. primary completion date: July 8, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Implant Breast Reconstruction

Intervention

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.

Locations

Country	Name	City	State
China	Xinhong Wu	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants with removal of implant.	Implant are removed for postoperative complications.	6 months after surgery
Secondary	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
Secondary	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