Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
NCT ID: NCT03589924
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
440 participants
INTERVENTIONAL
2018-06-01
2024-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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One step method
Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
Immediate IBBR+TiLoop®Bra
Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra
Two step method
Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
Immediate-delayed IBBR+TiLoop®Bra
Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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First Hospital of China Medical University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Jiong Wu
OTHER
Responsible Party
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Jiong Wu
professor
Principal Investigators
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Jiong Wu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Hebei Cancer Hospital
Shijiazhuang, Hebei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The first hospital of China medical university
Shengyang, Liaoning, China
Liaoning Cancer Hospital & Insitute
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Chi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19.
Other Identifiers
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CBCSG-040
Identifier Type: -
Identifier Source: org_study_id
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