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

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.

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.

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.

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.