Can patients with multiple breast cancers in the same breast avoid mastectomy by having multiple lumpectomies to achieve equivalent rates of local breast cancer recurrence? A randomized controlled feasibility trial called MIAMI UK (NCT03514654)

Winters, Zoë E.; Jones, Louise; Schmidt, Peter; Brunt, Murray; Maxwell, Anthony; Ingram, Jenny; Greenwood, Rosemary; Kandiyali, Rebecca; Roberts, Nick; Brew-Graves, Chris; Potyka, Ingrid; Williams, Norman

Abstract

Background: Oncological safety of treating multiple ipsilateral breast cancers (MIBC) using therapeutic mammoplasty (TM) compared to mastectomy remains uncertain. A National Institute for Health Research (NIHR)—funded MIAMI feasibility phase randomized controlled trial (RCT) aims to demonstrate that sufficient numbers of eligible patients can be identified and accept randomization.

Methods: Phase 3 un-blinded prospective UK RCT. Initially, aims to recruit 50 women with MIBC > 40 years randomized in a 2:1 ratio to multiple lumpectomies and TM compared to mastectomy ± reconstruction. No limitations of numbers of cancer foci with multifocal resectable by a single lumpectomy and multicentric cancers requiring separate lumpectomies. Radiation therapy (RT) will mirror IMPORT HIGH and FAST FORWARD, with individualized planning for potential dual lumpectomy RT boosts.

Results: So far 2 patients have been randomised into the trial. Ten centres have screened 1607 invasive cancers (June 2018–Sep 2019). MIBC were diagnosed in 186 women (11.5%). Most women were ineligible for MIAMI (n = 1361, 84.7%) with 5 invited to trial participation (2 accepted and 3 declined participation). Amongst the three decliners, two expressed uncertainty about the best treatment, potentially facilitating randomization, however all three expressed strong worries regarding randomization. Two preferred a mastectomy, and the other electing TM.

Discussion: MIAMI is a world-first first RCT investigating clinical and cost-effectiveness of TM being oncologically equivalent to mastectomy ± reconstruction in MIBC. The feasibility phase will inform the design of the main RCT.

Citation

Winters, Z. E., Jones, L., Schmidt, P., Brunt, M., Maxwell, A., Ingram, J., …Williams, N. (2020, February). Can patients with multiple breast cancers in the same breast avoid mastectomy by having multiple lumpectomies to achieve equivalent rates of local breast cancer recurrence? A randomized controlled feasibility trial called MIAMI UK (NCT03514654). Paper presented at UK Interdisciplinary Breast Cancer Symposium 2020

• Presentation Conference Type: Conference Paper (unpublished)
• Conference Name: UK Interdisciplinary Breast Cancer Symposium 2020
• Start Date: Feb 6, 2020
• Deposit Date: Jun 21, 2023
• DOI: https://doi.org/10.1007/s10549-019-05514-3
• Publisher URL: https://link.springer.com/article/10.1007/s10549-019-05514-3