Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augm… (NCT03589924) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
China440 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Rate of perioperative complications
Timeframe: Start of randomization until 3 months after surgery