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Breast CancerIBBRNCT03589924

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

A study testing Immediate IBBR+TiLoop®Bra and Immediate-delayed IBBR+TiLoop®Bra in people with Breast Cancer, run by Jiong Wu at 11 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Immediate IBBR+TiLoop®Bra and Immediate-delayed IBBR+TiLoop®Bra
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
11 sitesChina
Study dates
1 Jun 2018to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Sun Yat-sen Memorial Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 501120

  • Guangdong Women and Children Hospital

    Guangzhou, Guangdong, 511400

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310004

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Cancer Hospital/ Institute, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The first hospital of China medical university

    Shengyang, Liaoning, 110001

  • Liaoning Cancer Hospital & Insitute

    Shenyang, Liaoning, 110801

  • Hebei Cancer Hospital

    Shijiazhuang, Hebei, 050000

Other trials in China

About this study

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.

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Immediate IBBR+TiLoop®Bra, Immediate-delayed IBBR+TiLoop®Bra
Keywords
Immediate implant reconstruction, TiLoop® Bra
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate IBBR+TiLoop®BraProcedure or surgery

    Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra

  • Immediate-delayed IBBR+TiLoop®BraProcedure or surgery

    Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra

Study groups in NCT03589924
Study groupRoleWhat they receive
One step methodExperimentalImmediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
Receives: Procedure: Immediate IBBR+TiLoop®Bra
Two step methodActive comparatorImmediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
Receives: Procedure: Immediate-delayed IBBR+TiLoop®Bra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of perioperative complications

    The rate of perioperative complication between the two groups

    Measured: Start of randomization until 3 months after surgery

Secondary outcomes (5)

  1. 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.

    Measured: 18 months after surgery

  2. 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.

    Measured: 18 months after surgery

  3. 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" .

    Measured: 18 months after surgery

  4. Additional surgery

    The type of additional surgery following breast reconstruction

    Measured: 18 months after surgery

  5. Angiopathology-related assessment of Tiloop bra

    The angiopathology-related assessment in immediate-delayed reconstruction group

    Measured: 18 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start1 Jun 2018
  3. Primary completion30 Apr 2023
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589924
Sponsor's protocol ID
CBCSG-040
Acronym
IBBR
Status last verified
Jun 2024
First submitted
16 Jun 2018
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19.

    PubMed 37216212

Questions about this trial

What is this clinical trial studying?

A study testing Immediate IBBR+TiLoop®Bra and Immediate-delayed IBBR+TiLoop®Bra in people with Breast Cancer, run by Jiong Wu at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of perioperative complications (time frame: Start of randomization until 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589924, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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