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Breast CancerScarABEONCT06906237

Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study

An observational study of Breast Cancer and Oncoplastic Breast Surgery, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
250 participants
Where
1 siteItaly
Study dates
18 Apr 2024to 1 Dec 2026
Phase
Observational
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Female Patients who underwent OBCS with CWPFs for breast cancer, with at least one-year follow-up

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

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

Italy1 site, 1 recruiting
  • Veneto Institute of Oncology

    Padova, 35128

    Massimo Ferrucci, +393331779209, massimoferrucci@gmail.com

    Daniele Passeri, +393333839397, daniele.passeri.1995@gmail.com

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Medical subject headings
Breast Neoplasms

What is being measured

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

  1. Margin infiltration rate

    Margin infiltration rate in Patients with breast cancer or ductal carcinoma in situ who underwent Oncoplastic Breast Conserving Surgery with Chest Perforator Flaps

    Measured: Perioperative

Secondary outcomes (6)
  1. Re-excisions rate

    Re-excisions rate due to positive margins rate on surgical specimen

    Measured: Up to 24 weeks

  2. Total resection volume and final breast volume ratio

    Measured: Perioperative

  3. Post-operative complication rates

    Measured: Up to 24 weeks

  4. Post-operative breast symmetry

    Measured: One year

  5. Disease-free survival

    Measured: Two years

  6. Overall Survival

    Measured: Two years

Timeline

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

  1. First posted2 Apr 2025
  2. Study start18 Apr 2024
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906237
Sponsor's protocol ID
CET ANV 2024-23
Acronym
ScarABEO
Status last verified
Mar 2026
First submitted
7 Mar 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Oncoplastic Breast Surgery, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.

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 4 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: looking for participants now, as of the sponsor's last update on 27 Mar 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 Italy. 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?

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 Massimo Ferrucci (+39 3331779209, massimoferrucci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Margin infiltration rate (time frame: Perioperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Mar 2026.

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ScarABEO Clinical Trial NCT06906237 | AzTrials