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Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Primary Purpose

Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant radiotherapy
Sponsored by
Hubei Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring neoadjuvant radiotherapy, implant, breast reconstruction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Xinhong WuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant radiotherapy group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of participants with removal of implant.
Implant are removed for postoperative complications.
Patient satisfaction.
Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, 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).

Full Information

First Posted
August 5, 2023
Last Updated
August 8, 2023
Sponsor
Hubei Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05992870
Brief Title
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Official Title
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2023 (Actual)
Primary Completion Date
July 8, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy
Keywords
neoadjuvant radiotherapy, implant, breast reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinhong Wu, MD
Phone
+8618602726300
Email
34053889@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Zou, MD
Phone
+8615007162698
Email
sunnyning116@163.com
Facility Information:
Facility Name
Xinhong Wu
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhong Wu, MD
Phone
+8618602726300
Email
34053889@qq.com
First Name & Middle Initial & Last Name & Degree
Ning Zou, MD
Phone
+8615007162698
Email
sunnyning116@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Learn more about this trial

Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

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