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

The PreQ-20 TRIAL, a Prospective Cohort Study of the Oncologic Safety, Quality of Life and Cosmetic Outcomes of Patients Undergoing Prepectoral Breast Reconstruction

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Breast Cancer; Surgery--Complications
• Intervention / Treatment: Procedure: Prepectoral reconstruction

Detailed Description

1. Mastectomy technique. The breast removal will be performed using a mastectomy adapted to the breast and optimizing the preservation of the breast's original elements (inframammary fold, skin envelope, fat transitions, nipple-areolar complex) according to each patient's anatomical and oncologic possibilities.
2. Reconstruction technique. The reconstruction will be performed by placing a silicone implant coated with polyurethane foam in the prepectoral position.
3. Preoperative assessment. All patients will be assessed by a surgeon of the breast unit. The decision for the mastectomy will be made in consensus with the multidisciplinary committee. Before the surgery, the patients will undergo a mammography and magnetic resonance imaging to confirm the tumor size and rule out multifocality/multicentricity, as well as an evaluation of the distribution of glandular tissue and transitions between the breast and chest wall.
4. Breast magnetic resonance imaging. This study will employ the first magnetic resonance imaging during the postoperative period (between 12 and 18 months) to assess the residual glandular tissue following the mastectomy.
5. BreastQ questionnaire. The BreastQ questionnaire is aimed at evaluating patient-reported satisfaction and quality of life through the use of breast reconstruction modules. The preoperative format, which is delivered to patients before the surgery, and the postoperative format, which is delivered to them 12-18 months after the surgery. Likewise, we will conduct a second postoperative assessment at 5 years of the surgery.

d. Images. The evaluation of the cosmetic sequelae requires taking photographs of the patient's chest (from the suprasternal notch to navel). Photographs will be taken prior to the surgery (frontal, right and left lateral), then again at 12-18 months and finally at 5 years of the surgery.

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Hospital Abente y Lago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prepectoral Reconstruction; Women with breast cancer or with high risk for breast cancer in whom a sparing mastectomy and prepectoral reconstruction was performed	Procedure: Prepectoral reconstruction; Immediate prepectoral breast reconstruction in women requiring a mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of residual glandular tissue (Safety)	To evaluate the safety of sparing mastectomy through the identification of residual glandular tissue through a magnetic resonance one year after surgery	1 year after surgery
Incidence of breast cancer relapse (oncological safety)	To evaluate the safety of sparing mastectomy through the identification relapses in the same breast during the follow up	yearly, up to 5 years. From surgery date until the date of documented realapse
Incidence of new breast cancer (safety of risk reducing mastectomy)	To evaluate the safety of risk reducing sparing mastectomy in high risk for breast cancer patientes through the identification of new breast cancer	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	To assess satisfaction and quality of life after prepectoral reconstruction in women with breast cancer and those with high risk through breastQ questionnaire To identify factors related to satisfaction and quality of life after prepectoral reconstruction (e.g. marital status, psychological illnesse)	1 year and 5 year after surgery
Incidenca of cosmetic sequelae	To evaluate the cosmetic sequelae after prepectoral reconstruction in women with breast cancer and with high risk and Identify factors related to the cosmetic sequelae after prepectoral reconstruction. The investigators will employ the Clough classification, where type I sequelae identified the patients with breast asymmetry but no deformity, type II sequelae were defined by the presence of a deformity that could be corrected using a breast-conserving procedure, and type III sequelae identified those women whose breast showed a deformity or painful fibrosis that could only be solved through mastectomy. To determine the sequelae, the criteria of the breast surgeon will be used, documented through photos.	yearly, up to 5 years. From surgery date until the date of first documented cosmetis sequelae

Collaborators and Investigators

• Sponsor: University Hospital A Coruña
• Investigators: Principal Investigator: Benigno Acea Nebril, PhD., University Hospital A Coruna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Prepectoral Reconstruction; Sparing Mastectomy; Risk reducing mastectomy; Breast Q
• Other Study ID Numbers: 2020/295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No