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

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ClinicalTrials.gov Identifier: NCT03589924
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborators:
First Hospital of China Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Guangdong Provincial People's Hospital
The First Affiliated Hospital with Nanjing Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Jiong Wu, Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Immediate IBBR+TiLoop®Bra Procedure: Immediate-delayed IBBR+TiLoop®Bra Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All patients will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : July 30, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of Complications [ Time Frame: 18 months after surgery ]
    The rate of complication between the two groups


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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" .

  4. Additional surgery [ Time Frame: 18 months after surgery ]
    The type of additional surgery following breast reconstruction

  5. Angiopathology-related assessment of Tiloop bra [ Time Frame: 18 months after surgery ]
    The angiopathology-related assessment in immediate-delayed reconstruction group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589924


Contacts
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Contact: Jiong Wu 862164175590 wujiong1122@vip.sina.com
Contact: Benlong Yang 862164175590 yblqhdx@163.com

Locations
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China, Guangdong
Sun Yat-sen Memorial Hospital,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 501120
Contact: Nanyan Rao         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ning Liao         
China, Hangzhou
The Second Affiliated Hospital of Zhejiang University Recruiting
Zhejiang, Hangzhou, China, 310009
Contact: Yiding Chen         
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Jingping Shi         
China, Liaoning
The first hospital of China medical university Recruiting
Shengyang, Liaoning, China, 110001
Contact: Siyuan Han         
China, Shanghai
Cancer Hospital/ Institute, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jiong Wu, M.D    862164175590    wujiong1122@vip.sina.com   
Contact: Benlong Yang, Ph.D.    862164175590    yblqhdx@163.com   
Sponsors and Collaborators
Jiong Wu
First Hospital of China Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Guangdong Provincial People's Hospital
The First Affiliated Hospital with Nanjing Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Jiong Wu, M.D. Fudan University

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Responsible Party: Jiong Wu, professor, Fudan University
ClinicalTrials.gov Identifier: NCT03589924    
Other Study ID Numbers: CBCSG-040
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiong Wu, Fudan University:
Immediate implant reconstruction
TiLoop® Bra