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

December 26, 2023 updated by: Jiong Wu

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 501120
        • Recruiting
        • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
        • Contact:
          • Nanyan Rao
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • Guangdong Women and Children Hospital
        • Contact:
          • Antai Zhang
    • Hebei
      • Shijia Zhuang, Hebei, China, 050000
        • Recruiting
        • Hebei Cancer Hospital
        • Contact:
          • Cuizhi Geng
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Jingping Shi
    • Liaoning
      • Shengyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Siyuan Han
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital & Insitute
        • Contact:
          • Qiang Zhang
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Haibo Wang
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Cancer Hospital/ Institute, Fudan University
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University
        • Contact:
          • Yiding Chen
      • Hangzhou, Zhejiang, China, 310004
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
          • Wenhe Zhao
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
        • Contact:
          • Jian Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One step method
Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
Procedure: Immediate IBBR+TiLoop®Bra
Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra
Active Comparator: Two step method
Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
Procedure: Immediate-delayed IBBR+TiLoop®Bra
Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of perioperative complications
Time Frame: Start of randomization until 3 months after surgery
The rate of perioperative complication between the two groups
Start of randomization until 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life:EORTC QLQ C30 /+ BR23 questionnaire
Time Frame: 18 months after surgery

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
Patient satisfaction:Breast-Q questionnaire
Time Frame: 18 months after surgery

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
Aesthetic score of reconstructed breast
Time Frame: 18 months after surgery
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
Additional surgery
Time Frame: 18 months after surgery
The type of additional surgery following breast reconstruction
18 months after surgery
Angiopathology-related assessment of Tiloop bra
Time Frame: 18 months after surgery
The angiopathology-related assessment in immediate-delayed reconstruction group
18 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiong Wu

Collaborators

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

Investigators

  • Principal Investigator: Jiong Wu, M.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2018

Primary Completion (Actual)

April 30, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

June 16, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CBCSG-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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