Clinical trial NCT03589924: Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Immediate implant reconstruction
TiLoop® Bra
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: The First Affiliated Hospital with Nanjing Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2018-07-18
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of perioperative complications
timeFrame: Start of randomization until 3 months after surgery
Secondary outcomes:
measure: Quality of life:EORTC QLQ C30 /+ BR23 questionnaire
timeFrame: 18 months after surgery
measure: Patient satisfaction:Breast-Q questionnaire
timeFrame: 18 months after surgery
measure: Aesthetic score of reconstructed breast
timeFrame: 18 months after surgery
measure: Additional surgery
timeFrame: 18 months after surgery
measure: Angiopathology-related assessment of Tiloop bra
timeFrame: 18 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Women and Children Hospital
state: Guangdong
city: Shijia Zhuang
country: China
facility: Hebei Cancer Hospital
state: Hebei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shengyang
country: China
facility: The first hospital of China medical university
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Insitute
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Cancer Hospital/ Institute, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Jiong Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: