Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
IBBR
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.
1 other identifier
interventional
440
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jun 2018
Longer than P75 for not_applicable breast-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJune 21, 2024
June 1, 2024
4.9 years
June 16, 2018
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of perioperative complications
The rate of perioperative complication between the two groups
Start of randomization until 3 months after surgery
Secondary Outcomes (5)
Quality of life:EORTC QLQ C30 /+ BR23 questionnaire
18 months after surgery
Patient satisfaction:Breast-Q questionnaire
18 months after surgery
Aesthetic score of reconstructed breast
18 months after surgery
Additional surgery
18 months after surgery
Angiopathology-related assessment of Tiloop bra
18 months after surgery
Study Arms (2)
One step method
EXPERIMENTALImmediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
Two step method
ACTIVE COMPARATORImmediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
Interventions
Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra
Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 501120, China
Guangdong Women and Children Hospital
Guangzhou, Guangdong, 511400, China
Hebei Cancer Hospital
Shijiazhuang, Hebei, 050000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The first hospital of China medical university
Shengyang, Liaoning, 110001, China
Liaoning Cancer Hospital & Insitute
Shenyang, Liaoning, 110801, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310004, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009, China
Related Publications (1)
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.
PMID: 37216212DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiong Wu, M.D.
Fudan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 16, 2018
First Posted
July 18, 2018
Study Start
June 1, 2018
Primary Completion
April 30, 2023
Study Completion
September 30, 2024
Last Updated
June 21, 2024
Record last verified: 2024-06