NCT03514654: MIAMI

MIAMI Safe Surgery for Multiple Breast Cancers

Completed NA Last updated 18 May 2021

What this trial tests

NA trial testing Mastectomy in Breast Cancer, Unilateral in 4 participants. Completed in 31 October 2020.

Timeline

1 November 2017

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	University College, London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	1 November 2017
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	7 locations across United Kingdom

Drugs / interventions tested

• Mastectomy
• Therapeutic Mammoplasty

Conditions studied

• Breast Cancer, Unilateral — all drugs for Breast Cancer, Unilateral →

Sponsor

University College, London

Who can join

40 and older, female only, with Breast Cancer, Unilateral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sometimes women have more than one breast cancer in the same breast at the same time. These women are usually offered a mastectomy (removal of that breast) and breast reconstruction. It may be possible to treat these patients by removing each cancer using breast-saving surgery (lumpectomies), used for women with only one breast cancer. Databases show that women who had lumpectomies did well, but they may have been healthier before the surgery than those who had a mastectomy. The investigators need to be sure that lumpectomy is effective, safe, and acceptable for this patient group before making it universally available.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer on recruitment to a surgical randomised controlled feasibility trial.
   Ingram J, Beasant L, Benson J, Brunt AM, et al · · 2022 · cited 9× · PMID 35227311 · DOI 10.1186/s40814-022-01007-1
2. The Challenge of Equipoise: Qualitative Interviews Exploring the Views of Health Professionals and Women With Multiple Ipsilateral Breast Cancer in a Surgical Randomised Controlled Trial.
   Ingram J, Beasant L, Benson J, Brunt AM, et al · · 2021 · DOI 10.21203/rs.3.rs-386168/v2