Prepectoral and Subpectoral Implant-based Breast Reconstruction

A Multicentric, Open-labeled, Prospective, Randomized Controlled Study to Compare the Satisfaction and Safety of the Prepectoral and Subpectoral Implant-based Breast Reconstruction in Patients Receiving Immediate Breast Reconstruction Using Implant Combined With TiLoop® Bra After Skin Sparing or Nipple-areola Sparing Mastectomy

Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase year by year, while implant reconstruction has become the most important way of breast reconstruction due to its less injury, shorter time of operation and relatively simple surgical technique. In the long-term clinical practice, due to the lack of safe and effective alternative methods, the reconstruction method with prosthesis placed to posterior pectoralis major has been accepted by surgeons and patients, and has become the most commonly used method of prosthesis construction. However, the development of biomaterials provides new ideas for breast reconstruction. At present, more and more doctors in clinical practice discontinue the use of serratus anterior, but use the synthetic mesh (mostly titanium mesh TiLoop® Bra) or allogeneic acellular dermal matrix mesh to cover part of the dilator or prosthesis so as to shorten the entire operation cycle and make the appearance of the reconstructed breast more natural and aesthetic. In particular, it can improve the contour of the folds under the breast and shape the breasts with a certain degree of sagging.

This study takes the patients receiving immediate reconstruction with an implant combined with TiLoop® Bra after total mastectomy as the subjects, aiming to compare the aesthetics and safety of the placement of implant to anterior and posterior pectoralis major through a prospective and randomized study. The primary objective of the study is to analyze the aesthetics of breast appearance, patient satisfaction and postoperative quality of life (QOL) of the placement of implant to anterior and posterior pectoralis major. The secondary objective of the study is to analyze the incidence of complications and type of reoperation in both groups.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Carcinoma; Breast Reconstruction
• Intervention / Treatment: Procedure: prepectoral implant-based reconstruction; Procedure: subpectoral implant-based reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. More than 18 years old
2. Female
3. Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
4. Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
5. Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
6. No clinical or imaging evidence of distant metastasis
7. Patients to receive skin sparing mastectomy or nipple sparing mastectomy
8. BMI < 35
9. Patients with no or mild mastoptosis
10. Prosthesis to be implanted <500 ml
11. Be able and willing to sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
2. BMI>=35
3. Patients who have received symmetrical breast surgery on the unaffected side immediately or later
4. Patients with locally advanced breast cancer to receive neoadjuvant therapy
5. Patients currently participating in other clinical trials, which may have impact on the participation in this trial
6. Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
7. Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
8. Pregnancy breast-feeding women
9. History of smoking
10. Previous history of diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prepectoral Group; Prepectoral implant-based reconstruction applied for patients in this group	Procedure: prepectoral implant-based reconstruction; In this group, patients receive breast reconstruction with prosthesis placed to anterior pectoralis major, synthetic mesh is used to enclose the prosthesis and place it to anterior pectoralis major.
Active Comparator: Subpectoral Group; Subpectoral implant-based reconstruction applied for patients in this group	Procedure: subpectoral implant-based reconstruction; In this group, patients receive breast reconstruction with placed to posterior pectoralis major, part of the mesh is placed under the pectoralis major during the operation, and the mesh is used to cover the suture of the prosthesis on the inferior plica, or to directly enclose the lower part of the implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' satisfaction	Patients' satisfaction evaluated based on Breast-Q scale	18 months after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidences of complications and serious complications	Incidences of complications and serious complications	During 18 months after the operation

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): December 27, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: December 25, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Complication; breast carcinoma; breast reconstruction; Prepectoral prosthetic breast reconstruction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PSIBBR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

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