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

June 19, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Guangdong Women and Children Hospital
      • Guangzhou, Guangdong, China, 501120
        • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
    • Hebei
      • Shijia Zhuang, Hebei, China, 050000
        • Hebei Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
    • Liaoning
      • Shengyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110801
        • Liaoning Cancer Hospital & Insitute
    • Shandong
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Cancer Hospital/ Institute, Fudan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University
      • Hangzhou, Zhejiang, China, 310004
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310006
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiong Wu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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