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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Immediate IBBR+TiLoop®Bra
* Procedure: Immediate-delayed IBBR+TiLoop®Bra


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perioperative complications | 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 | 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 | 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 | 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 | The type of additional surgery following breast reconstruction | 18 months after surgery | 
| Angiopathology-related assessment of Tiloop bra | The angiopathology-related assessment in immediate-delayed reconstruction group | 18 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate implant reconstruction, TiLoop® Bra