MIAMI Controlled Trial

Overview

Traditionally patients who were diagnosed with multiple ipsilateral breast cancers underwent mastectomy +/- breast reconstruction. However, modern surgical techniques such as therapeutic mammoplasty enable these cancers to be removed without requiring a mastectomy. The MIAMI study will aim to determine if therapeutic mammoplasty is equally safe as mastectomy in terms of achieving local control, as well as the women’s quality of life, satisfaction with appearance of their breasts, and costs of the surgery types. This feasibility trial will evaluate whether a sufficient number of eligible patients can be identified and are willing to accept randomisation of the two interventions in question. The recruitment and compliance rates will inform the feasibility and design of a larger trial. Patients will be randomised (1:1) into either intervention or control group.

Objectives

This is a multicentre randomised controlled feasibility study to evaluate whether patients with multiple cancers in the same breast avoid a mastectomy by having therapeutic mammoplasty to achieve equivalent rate of breast cancer local recurrence.

Primary outcome measure

Feasibility of a larger trial, assessed using:

• Numbers of women with multiple ipsilateral breast cancer screened for the trial by 36 months
• Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty by 36 months
• The proportion of women eligible for the trial who provide written informed consent by 36 months
• Rate of compliance with allocated treatment and reason for deviation by 36 months

Secondary outcome measures

• Reasons why patients accept or decline randomisation, assessed from patient-completed Qualitative Study questionnaire
• Views of clinical staff assessed using qualitative interviews
• Views of participating patients assessed using qualitative interviews

Inclusion criteria

• Women aged >40 years with multiple ipsilateral breast cancer
• Minimum of two invasive foci of breast cancer
• Suitable for Therapeutic Mammoplasty
• Fit for adjuvant therapy
• Willing and able to provide written informed consent

Exclusion criteria

• Neo-adjuvant therapy 

• Women considered high risk by local centre or known to have BRCA1/2 gene mutation
• Ductal Carcinoma in situ (DCIS) only, and extensive DCIS 

  Bilateral breast cancers
• Previous breast cancer (invasive or DCIS in either breast) 

• Pregnancy as confirmed on blood tests or ultrasound examination
• Metastatic disease
• Any previous type of breast radiotherapy 

• Significant other clinical risk factors and co-morbidities at the discretion of the treating clinicians
• Previous or concomitant malignancy except adequately treated:

• non-melanomatous skin cancer
• in situ carcinoma of the cervix and
• in situ melanoma

Planned sample size

50 participants

Total number of sites planned

25 UK breast units have been designated as recruiting sites for the study.