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Breast CancerPhase 3DETE-BRNCT07593846

The Comparison Between DEDTI BR and T/E BR

A Phase 3 study testing Delayed endoscopic direct-to-implant breast reconstruction and Two-stage expander-to-implant breast reconstruction in people with Breast Cancer, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Delayed endoscopic direct-to-implant breast reconstruction and Two-stage expander-to-implant breast reconstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
1 siteChina
Study dates
1 May 2026to 31 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer;
  • At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity;
  • Voluntary provision of informed consent.

Who cannot join

  • Local/regional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence);
  • Pectoralis major muscle was resected during the initial surgery;
  • Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery;
  • Immunodeficiency;
  • Long-term smoking history or poorly controlled diabetes mellitus;
  • Currently participating in other clinical trials that may affect the results of this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenggui Du contact

+86 13880768222

docduzg@163.com

China1 site

  • West China hospital of Sichuan University

    Chengdu

    Zhenggui Du, +86 13880768222, docduzg@163.com

Other trials in China

About this study

Official title: A National Multicenter, Prospective, Cohort Study Comparing Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Axillary Approach With the Two-Stage Expander-to-Implant Breast Reconstruction Following Simple Mastectomy

This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.

Read the detailed description

Breast cancer is one of the most prevalent malignant tumors among women, with comprehensive treatment primarily centered around surgery being the mainstay approach. Mastectomy accounts for 88.8% of primary breast cancer surgeries, yet the rate of immediate breast reconstruction is only about 10.7%, resulting in the majority of patients losing their breasts at the time of initial surgery and suffering from long-term suboptimal psychosocial health, with divorce rates reaching as high as 40%. With the improvement in breast cancer treatment outcomes, an increasing number of women hope to improve postoperative breast morphology and alleviate psychological trauma through breast reconstruction. Traditional reconstruction methods include autologous tissue reconstruction and prosthetic reconstruction. The former involves significant trauma and a high incidence of complications, while the latter often requires a two-stage approach due to insufficient skin tissue, involving initial placement of a tissue expander followed by replacement with a prosthetic implant, which increases the number of surgeries and the risk of complications.

To address this issue, our team has developed a novel delayed endoscopic direct-to-implant breast reconstruction technique via an axillary incision approach with insufflation, which requires only a single surgery, significantly reducing surgical time, trauma, and costs, as well as the incidence of complications. Postoperatively, there are no fresh incisions on the breast, resulting in a more natural appearance and softer feel. This study aims to compare this technique with the traditional two-stage approach, exploring postoperative complications, aesthetic outcomes, quality of life, cost-effectiveness, and surgical-related indicators. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are required to provide evidence-based medical evidence and optimize surgical strategies.

Therefore, this national multicenter, prospective, cohort study will compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.

Conditions
Breast Cancer
Being tested
Delayed endoscopic direct-to-implant breast reconstruction, Two-stage expander-to-implant breast reconstruction
Keywords
Breast Cancer, Endoscopic surgery, Minimal invasive surgery, Breast Reconstruction
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Delayed endoscopic direct-to-implant breast reconstructionProcedure or surgery

    This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.

  • Two-stage expander-to-implant breast reconstructionProcedure or surgery

    The two-stage expander-to-implant breast reconstruction involves initially placing a tissue expander to stretch the skin. Once the skin has sufficient capacity, a second surgery is performed to replace the expander with a breast implant. The expander can be gradually adjusted based on the patient's skin expansion progress, physical recovery, and aesthetic needs to achieve optimal reconstruction results.

Study groups in NCT07593846
Study groupRoleWhat they receive
DEDTI groupExperimentalDelayed endoscopic direct-to-implant breast reconstruction
Receives: Procedure: Delayed endoscopic direct-to-implant breast reconstruction
T/E groupExperimentalTwo-stage expander-to-implant breast reconstruction
Receives: Procedure: Two-stage expander-to-implant breast reconstruction

What is being measured

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

  1. Surgical complication rates

    Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis.

    Measured: Postoperative 2 years

Secondary outcomes (11)

  1. Operation time

    The surgical time includes total anesthesia time, total operative time, and flap dissociation time.

    Measured: Intraoperative

  2. Number of operations

    The number of surgical procedures performed, representing the total count of operations conducted.

    Measured: Intraoperative

  3. Contralateral breast adjustment operation rates

    The rate of contralateral breast adjustment operations, defined as the proportion of patients who undergo additional surgical procedures to modify or adjust the contralateral (opposite) breast to achieve symmetry with the reconstructed breast.

    Measured: Intraoperative

  4. Surgery-related costs

    Surgery-related costs include total hospitalization expenses, surgical costs, postoperative dressing change costs, expander injection costs, etc.

    Measured: Postoperative 1 month

  5. Aesthetic outcomes (BREAST-Q score)

    The BREAST-Q scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores.

    Measured: Postoperative 6 months and 2 years

  6. Aesthetic outcome (SCAR-Q score)

    A validated scar-specific patient-reported outcome measure tool for assessing the quality of life of patients with scars. It consists of three independent scales: scar appearance, scar symptoms, and psychosocial impact. Transformed scores range from 0 to 100, with higher scores indicating better outcomes.

    Measured: Postoperative 6 months and 2 years

  7. Aesthetic outcome (Harris score)

    The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).

    Measured: Postoperative 6 months and 2 years

  8. Aesthetic outcome (Ueda score)

    Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented.

    Measured: Postoperative 6 months and 2 years

  9. Quality of Life (EORTC Quality of Life scores)

    EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms.

    Measured: Postoperative 6 months and 2 years

  10. Implant-assisted complications

    Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, prosthesis rotation.

    Measured: Postoperative 6 months and 2 years

  11. Divorce rates

    Divorce rates

    Measured: Postoperative 6 months and 2 years

Timeline

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

  1. First posted18 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07593846
Sponsor's protocol ID
2025 (1442)
Acronym
DETE-BR
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.

Publications

  • Di Giuli R, Cavallero MF, Ferrari C, Vaccari S, Bucci F, Bandi V, Klinger FM, Vinci V. Two-stage prepectoral breast reconstruction: A comprehensive review and meta-analysis. J Plast Reconstr Aesthet Surg. 2025 May;104:388-397. doi: 10.1016/j.bjps.2025.02.041. Epub 2025 Feb 25.

    PubMed 40168922

  • Min K, Jeon DN, Han HH, Kim EK, Eom JS. Inframammary Fold Approach for Second-stage Operation in Expander-Implant Breast Reconstruction. Ann Plast Surg. 2021 Nov 1;87(5):501-505. doi: 10.1097/SAP.0000000000002629.

    PubMed 33346535

  • Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.

    PubMed 37410610

  • Atiyeh B, Chahine FM. Two-Stage Implant-Based Breast Reconstruction: An Evolution of the Conceptual and Technical Approach over a Two-Decade Period. Plast Reconstr Surg. 2017 Jul;140(1):227e-228e. doi: 10.1097/PRS.0000000000003467. No abstract available.

    PubMed 28272276

  • Cordeiro PG, McCarthy CM. A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications. Plast Reconstr Surg. 2006 Sep 15;118(4):825-831. doi: 10.1097/01.prs.0000232362.82402.e8.

    PubMed 16980842

  • Dikmans RE, Negenborn VL, Bouman MB, Winters HA, Twisk JW, Ruhe PQ, Mureau MA, Smit JM, Tuinder S, Eltahir Y, Posch NA, van Steveninck-Barends JM, Meesters-Caberg MA, van der Hulst RR, Ritt MJ, Mullender MG. Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial. Lancet Oncol. 2017 Feb;18(2):251-258. doi: 10.1016/S1470-2045(16)30668-4. Epub 2016 Dec 22.

    PubMed 28012977

  • Bellini E, Pesce M, Santi P, Raposio E. Two-Stage Tissue-Expander Breast Reconstruction: A Focus on the Surgical Technique. Biomed Res Int. 2017;2017:1791546. doi: 10.1155/2017/1791546. Epub 2017 Dec 10.

    PubMed 29376067

  • Ostapenko E, Nixdorf L, Devyatko Y, Exner R, Wimmer K, Fitzal F. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Systemic Review and Meta-analysis. Ann Surg Oncol. 2023 Jan;30(1):126-136. doi: 10.1245/s10434-022-12567-0. Epub 2022 Oct 16.

    PubMed 36245049

  • Yin Z, Wang Y, Sun J, Huang Q, Liu J, He S, Han C, Wang S, Ding B, Yin J. Association of sociodemographic and oncological features with decision on implant-based versus autologous immediate postmastectomy breast reconstruction in Chinese patients. Cancer Med. 2019 May;8(5):2223-2232. doi: 10.1002/cam4.2133. Epub 2019 Apr 5.

    PubMed 30950238

  • Yang B, Ren G, Song E, Pan D, Zhang J, Wang Y, Liao N, Tang J, Wang X, Cui S, Jin F, Geng C, Sun Q, Li H, Fan Z, Cao X, Wang H, Wang S, Shao Z, Wu J. Current Status and Factors Influencing Surgical Options for Breast Cancer in China: A Nationwide Cross-Sectional Survey of 110 Hospitals. Oncologist. 2020 Oct;25(10):e1473-e1480. doi: 10.1634/theoncologist.2020-0001. Epub 2020 May 13.

    PubMed 32333626

  • Zhao R, Jin M, Gao J, Zhang L, Tao L, Bao X. A Cross-Sectional Study of Breast Cancer Surgery and the Cost Based on Data From 77 Chinese 3A Hospitals in 2015. Front Oncol. 2022 Apr 26;12:857359. doi: 10.3389/fonc.2022.857359. eCollection 2022.

    PubMed 35558511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Delayed endoscopic direct-to-implant breast reconstruction and Two-stage expander-to-implant breast reconstruction in people with Breast Cancer, run by West China Hospital at 1 site 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Zhenggui Du (+86 13880768222, docduzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical complication rates (time frame: Postoperative 2 years). 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 NCT07593846, which also lists 11 linked publications.

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 18 May 2026.

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The Comparison Between DEDTI BR and T/E BR | AzTrials