Autologous vs. Implant-based Breast Reconstruction (GoBreast II)

Vastra Gotaland Region

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Implant; Procedure: DIEP-flap

Study type: Interventional

Funder types: Other

Identifiers

NCT06195865

2023-04754-01

Details and patient eligibility

About

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biological female
• >18 years of age
• American Society of anesthesiologist classification (ASA) 1-2
• Patient must have had or be scheduled for a mastectomy
• Ability to give informed consent
• Ability to communicate in Swedish

Exclusion criteria

• ASA > 2
• BMI > 30 kg/m2
• Smoking1 radiotherapy to the breast in question.
• Radiotherapy is expected post-operatively.
• Locally advanced breast cancer
• Metastasised breast cancer
• Comorbidity and/or drugs that affect wound healing.
• Unstable psychiatric co-morbidity
• Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

Randomised DIEP flap

Active Comparator group

Treatment:

Procedure: DIEP-flap

Randomised implant-based

Active Comparator group

Treatment:

Procedure: Implant

Preference DIEP-flap

Active Comparator group

Treatment:

Procedure: DIEP-flap

Preference implant-based

Active Comparator group

Treatment:

Procedure: Implant