MIAMI Safe Surgery for Multiple Breast Cancers
MIAMI
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 Randomised Controlled Feasibility Study.
1 other identifier
interventional
4
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
May 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedMay 18, 2021
May 1, 2021
3 years
March 21, 2018
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of women screened
Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial
36 Months
Number of women eligible for the trial
Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
36 Months
Consent rate
The proportion of women eligible for the trial who provide written informed consent
36 Months
Compliance with trial procedures
Rate of compliance with allocated treatment and reason for deviation
36 Months
Secondary Outcomes (3)
Reasons why patients accept or decline randomisation
36 Months
Qualitative research (clinical staff)
36 Months
Qualitative research (patients)
36 Months
Study Arms (2)
Mastectomy +/- reconstruction
ACTIVE COMPARATOREither a simple mastectomy or skin sparing mastectomy technique will be used. Women in this arm will be offered either immediate or delayed breast reconstruction according to standard practice. Reconstructions will be followed by chemotherapy and/or endocrine therapy as determined by local clinicians . Chest wall and/or regional nodal radiotherapy will be prescribed according to local centre policy.
Therapeutic Mammoplasty
ACTIVE COMPARATORTherapeutic Mammoplasty (TM) comprises well-established surgical techniques involving volume displacement using breast reduction techniques, or volume replacement to maximize the volume of tissue that can be excised resulting in effective local control whilst maximizing cosmetic outcomes. This group will either have one "disease site" lumpectomy in the case of multifocal tumours or distant "disease site" lumpectomies in multicentric cancers.
Interventions
Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.
Eligibility Criteria
You may qualify if:
- \>40 years with MIBC, with the largest clinical cancer measuring 50mm as part of multifocal or multicentric "disease sites". 50mm may include the size of a single cancer and its surrounding small satellite cancers (6, 7). Clinically diagnosed (ultrasound and biopsy) either axillary lymph node negative or positive where axillary treatment depends on local policy
- Two disease foci with a minimum of one invasive focus of breast cancer as defined within a "disease site"
- Suitable for TM (best practice) using one large lumpectomy (multifocal) or any number of "distant" lumpectomies (multicentric) to excise "disease sites"
- Fit for adjuvant therapy as per pre-operative evaluations (ECG, Chest X-ray, blood biochemistry)
- Willing and able to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Addenbrooke's Hospital
Cambridge, United Kingdom
South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital
Glasgow, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
St. George's Hospital
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Royal Hampshire Hospital
Winchester, United Kingdom
Related Publications (1)
Ingram J, Beasant L, Benson J, Brunt AM, Maxwell A, Harvey JR, Greenwood R, Roberts N, Williams N, Johnson D, Winters Z. 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. Pilot Feasibility Stud. 2022 Feb 28;8(1):46. doi: 10.1186/s40814-022-01007-1.
PMID: 35227311DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zoe Winters
University College, London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Neither the patients nor the clinical team will be blinded to the trial arms of this study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2018
First Posted
May 2, 2018
Study Start
November 1, 2017
Primary Completion
October 31, 2020
Study Completion
October 31, 2020
Last Updated
May 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held on secure servers and will not be released to any third parties until all the main outputs from the studies have been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis by SITU and the Chief Investigator. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Chief Investigator and study group, the sponsor, and funders.