Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study

NCT ID: NCT06906237

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-18

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Breast conserving surgery followed by radiotherapy is the gold standard treatment for early breast cancer. Cases with unfavorable tumor volume to breast volume ratio or challenging localizations are at higher risk of margin infiltration or poor aesthetic outcomes. While margin infiltration represents one of the strongest predictors of local recurrence, unappealing cosmetic results may significantly impair survivors' quality of life. Over the past two decades, the adoption of oncoplastic breast conserving surgery (OBCS) techniques has shown promise in improving both oncological and aesthetic outcomes after breast cancer surgery. Partial breast volume reconstruction (PBR) after OBCS is obtained through volume displacement (which involves remodelling and redistributing glandular tissue) and volume replacement (when the volume used to reconstruct the defect comes from an extramammary site) techniques.

One of the greatest examples of volume replacement techniques in breast surgery involves the use of chest wall perforator flaps (CWPF). The use of these well-vascularized dermo-adipose flaps offers oncologically safe wide resection while obtaining excellent cosmetic outcomes. It is particularly suitable for patients with non-ptotic small to medium-sized breasts and cases with an unfavorable tumor volume to breast volume ratio. CWPFs can decrease mastectomy rates in breast cancer surgery, thus avoiding the disadvantages associated with implant-based reconstruction. Consequently, the need of contralateral simmetrization is also diminished.

CWPFs are vascularized by perforator arteries that arise from the chest wall (mainly branches of the axillary artery, or intercostal arteries deriving from the internal mammary artery). While cadaver labs and radiologic studies demonstrated a reliable and coherent localization of perforator arteries, the use of Doppler Ultrasound is often required to localize the perforators and test their reliability. Compared to the traditional myocutaneous flaps (such as the latissimus dorsi flap), CWPFs spare the underlying muscles minimizing donor site morbidity and enabling rapid post-operative recovery, low post-operative complication rates, post-operative pain, and loss of function. All these advantages may result in high levels of patients' satisfaction. Additionally, CWPFs avoid the microsurgical anastomoses required for free flaps.

All breast quadrants defects could be restored with CWPFs, with the Thoraco-Dorsal Artery Perforator (TDAP), Lateral-Thoracic Artery Perforators (LTAP) and Lateral Intercostal Artery Perforator (LICAP) Flaps particularly suitable for reconstructing lateral quadrant; the Anterior Intercostal Artery Perforator (AICAP) Flap for the lower quadrants and the Internal Mammary Artery Perforator (IMAP) Flaps for volume defects at inner quadrants.

Although existing literature reports promising results, the use of CWPFs remains emerging, and OBCS with CWPFs is currently limited to select high-volume breast centers. The collection of robust clinical data is essential to validate these potential advantages and facilitate the broader adoption of this technique.

This multicentric retrospective observational study aims to collect evidence about the surgical and oncological outcomes of OBCS with CWPFs, to evaluate the potential benefits associated with the use of this innovative technique.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Oncoplastic Breast Surgery Oncoplastic Breast-conserving Surgery Chest Wall Perforator Flap

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients treated with BCS combined with CWPFs for primary stage I-III invasive cancer (IC) or ductal carcinoma in situ (DCIS);
* Patients treated during the last 10 years (2015-2025);
* Patients aged 18 years or more;
* Cases with at least one-year follow-up.

Exclusion Criteria

* Male Patients;
* Patients aged less than 18 years;
* Patients who underwent traditional breast conserving surgery or OBCS with displacement techniques;
* Patients who underwent mastectomy;
* Patients who underwent implant-based reconstruction;
* Patients with unresectable breast cancer or metastatic disease;
* Patients who were lost during follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Veneto Institute of Oncology

Padua, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Massimo Ferrucci

Role: CONTACT

+39 3331779209

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Massimo Ferrucci

Role: primary

+393331779209

Daniele Passeri

Role: backup

+393333839397

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CET ANV 2024-23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.