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

Jiong Wu

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Immediate IBBR+TiLoop®Bra; Procedure: Immediate-delayed IBBR+TiLoop®Bra

Study type: Interventional

Funder types: Other

Identifiers

NCT03589924

CBCSG-040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

One step method

Experimental group

Description:

Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225

Treatment:

Procedure: Immediate IBBR+TiLoop®Bra

Two step method

Active Comparator group

Description:

Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225

Treatment:

Procedure: Immediate-delayed IBBR+TiLoop®Bra