Clinical trial · Interventional
The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
The PreQ-20 TRIAL, a Prospective Cohort Study of the Oncologic Safety, Quality of Life and Cosmetic Outcomes of Patients Undergoing Prepectoral Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk. The study's main objective is to assess the safety of prepectoral breast reconstruction in terms of postsurgical complications and the feasibility of reconstruction (loss of implants). The secondary objectives are to evaluate oncologic safety (local relapses, residual glandular tissue) and to identify factors related to quality of life and cosmetic sequelae. The evaluation of residual tissue will be conducted by magnetic resonance imaging 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the BreastQ questionnaire. An initial patient evaluation will be conducted 12-18 months after the surgery, and a second evaluation will be performed at 5 years. The estimated sample size is 81 patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prepectoral reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prepectoral Reconstruction
- description
- Women with breast cancer or with high risk for breast cancer in whom a sparing mastectomy and prepectoral reconstruction was performed
- interventionNames
- Procedure: Prepectoral reconstruction
Primary outcomes (2)
- measure
- Incidence of implant loss (Feasibility of recosntruction)
- timeFrame
- First year after surgery
- description
- To evaluate the feasibility of prepectoral reconstruction in terms of implant loss the first year after surgery, also during oncological treatment (example: chemotherapy) (Unit of mesure: number of implant loss)
- measure
- Incidence of surgical complications - reoperations (Safety)
- timeFrame
- 3 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * We will include all women operated on in the Breast Unit through skin sparing mastectomy/Nipple skin sparing mastectomy (unilateral or bilateral) and immediate reconstruction with prepectoral implantation. The study population will include 2 patient groups: 1. Women with breast carcinoma. This group consists of patients with a histological diagnosis of in situ or infiltrating breast carcinoma, either primary or metachronic, which requires mastectomy as the surgical treatment. 2. Women at high risk for breast cancer. This group consists of women evaluated at a high-risk consultation and whose reducing risk mastectomy has been approved by the tumor committee of the Breast Unit of University Hospital Complex of A Coruna. For this procedure, the patients should meet at least one of the following criteria: * Hereditary breast and ovarian cancer syndrome, either by demonstrated genetic mutation or through their family history. * Histological diagnosis of high-risk lesions (atypical hyperplasia, ductal carcinoma in situ, lobular carcinoma in situ) associated with family history. * High-risk criteria (genetic, histological, family) during the breast cancer follow-up. Exclusion Criteria: * Inability to undergo magnetic resonance imaging during the diagnosis and follow-up. * Inability to fill out the BREAST-Q questionnaire. * Unwillingness by the patient to participate in the study. * Breast sarcomas. * Benign breast tumors. * Prepectoral breast reconstruction using expanders. * Prepectoral reconstruction with mesh
References
Publications (1)
- DERIVEDAcea-Nebril B, Garcia-Novoa A, Garcia Jimenez L. The PreQ-20 TRIAL: A prospective cohort study of the oncologic safety, quality of life and cosmetic outcomes of patients undergoing prepectoral breast reconstruction. PLoS One. 2022 Jul 14;17(7):e0269426. doi: 10.1371/journal.pone.0269426. eCollection 2022. PMID 35834508