Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

Breast Cancer Clinical Trial

— IBBR  

Official title:

A Randomized Multicenter, Open, Prospective, Controlled Study-comparison of the Safety of Immediate One-stage Implant Based Breast Reconstruction(IBBR) Versus Two-stage Expander-Implant IBBR Augmented With TiLoop® Bra.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03589924
• Other study ID #: CBCSG-040
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.

Description:

Studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with TiLoop®Bra.

This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra in breast cancer patients.

The hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or Nipple-sparing mastectomy using TiLoop® Bra.

The current study is a randomized multicenter, open labeled, prospective, controlled study.

Participants were enrolled at six hospitals in different places of China. All participants will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.

Based on earlier experience, investigators calculated that the surgical complication rate was approximately 30 percent in the one-stage group and 25 percent in the two-stage group. Consider a dropout rate of 5%, a total of 450 patients, with 225 in each group, are needed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: September 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with histological proven invasive breast cancer or ductal carcinoma in situ;

• Clinical T1-T2 disease with no distant metastasis;

• Patient with clinical N0 status;

• Intent to receive NSM or SSM and implant based breast reconstruction;

• Signed consent to participate.

Exclusion Criteria:

• Patient with severe breast ptosis;

• Patient received ipsilateral breast reduction or enlargement;

• Locally advanced stage patients who received neoadjuvant chemotherapy or hormone therapy;

• Patients enrolled in other clinical trial which may as influence the outcome;

• Patients received neo-adjuvant therapy and will receive radiotherapy.

• History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);

• Patients of pregnancy or lactation.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Immediate IBBR+TiLoop®Bra
Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra
• Immediate-delayed IBBR+TiLoop®Bra
Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra

Locations

Country	Name	City	State
China	Guangdong Women and Children Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Cancer Hospital/ Institute, Fudan University	Shanghai	Shanghai
China	The first hospital of China medical university	Shengyang	Liaoning
China	Liaoning Cancer Hospital & Insitute	Shenyang	Liaoning
China	Hebei Cancer Hospital	Shijia Zhuang	Hebei

Sponsors (5)

Lead Sponsor	Collaborator
Jiong Wu	First Hospital of China Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of perioperative complications	The rate of perioperative complication between the two groups	Start of randomization until 3 months after surgery
Secondary	Quality of life:EORTC QLQ C30 /+ BR23 questionnaire	EORTC QLQ C30 /+ BR23(EORTC breast cancer-specific quality of life) questionnaire to evaluate quality of life.; Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including "not at all" for 1 score,"a little" for 2 score, "quit a bit" for 3 score and "very much" for 4 score. A higher score indicated a worse quality of life.	18 months after surgery
Secondary	Patient satisfaction:Breast-Q questionnaire	Breast-Q questionnaire to evaluate patients' satisfaction Using the reconstruction module of BREAST-Q to evaluate patient-reported outcome (PRO) of the surgery.For each subtheme, one or more BREAST-Q scales were developed to examine specific aspects of patient satisfaction.; Patient responses to each scale's items are transformed through the Q-Score scoring software to provide a total scale score that ranges from 0 to 100. For all BREAST-Q scales, a higher score means greater satisfaction.	18 months after surgery
Secondary	Aesthetic score of reconstructed breast	Harris evaluation system to evaluate patients' breast aesthetic after surgery. Harris evaluation system is a 4-staged subjective evaluation method scored as "excellent," "good," "fair," "poor" .	18 months after surgery
Secondary	Additional surgery	The type of additional surgery following breast reconstruction	18 months after surgery
Secondary	Angiopathology-related assessment of Tiloop bra	The angiopathology-related assessment in immediate-delayed reconstruction group	18 months after surgery