The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction

NCT04642508 | Active Not Recruiting DMC

• 1 other identifier: 2020/295
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Quality of Life; Surgery--Complications

Keywords

Prepectoral Reconstruction; Sparing Mastectomy; Risk reducing mastectomy; Breast Q

Outcome Measures

Primary Outcomes (2)

• Incidence of implant loss (Feasibility of recosntruction)

  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)

  First year after surgery

• Incidence of surgical complications - reoperations (Safety)

  To determine the global incidence of surgical complications, as well as the causes of complications in terms of: postoperative bleeding, skin necrosis, necrosis of the nipple areola complex, seroma and infection

  3 months after surgery

Secondary Outcomes (5)

• Incidence of residual glandular tissue (Safety)

  1 year after surgery

• Incidence of breast cancer relapse (oncological safety)

  yearly, up to 5 years. From surgery date until the date of documented realapse

• Incidence of new breast cancer (safety of risk reducing mastectomy)

  yearly, up to 5 years. From surgery date until the date of documented new breast cancer

• Quality of life and satisfaction after a mastectomy with prepectoral reconstruction, using the BreastQ questionnaire

  1 year and 5 year after surgery

• Incidenca of cosmetic sequelae

  yearly, up to 5 years. From surgery date until the date of first documented cosmetis sequelae

Study Arms (1)

Prepectoral Reconstruction

OTHER

Women with breast cancer or with high risk for breast cancer in whom a sparing mastectomy and prepectoral reconstruction was performed

Procedure: Prepectoral reconstruction

Interventions

Prepectoral reconstruction PROCEDURE

Immediate prepectoral breast reconstruction in women requiring a mastectomy

Prepectoral Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital A Coruña: lead

Study Sites (1)

Hospital Abente y Lago

A Coruña, Galicia, 15006, Spain

Location

Related Publications (1)

• Acea-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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Benigno Acea Nebril, PhD.

  University Hospital A Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Surgeon

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 24, 2020
• Study Start: June 22, 2020
• Primary Completion: November 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)