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MIAMI Safe Surgery for Multiple Breast Cancers (MIAMI)

Primary Purpose

Breast Cancer, Unilateral

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mastectomy
Therapeutic Mammoplasty
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer, Unilateral focused on measuring Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. >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
  2. Two disease foci with a minimum of one invasive focus of breast cancer as defined within a "disease site"
  3. Suitable for TM (best practice) using one large lumpectomy (multifocal) or any number of "distant" lumpectomies (multicentric) to excise "disease sites"
  4. Fit for adjuvant therapy as per pre-operative evaluations (ECG, Chest X-ray, blood biochemistry)
  5. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Neo-adjuvant therapy
  2. Women considered high risk by local centre or known to have BRCA1/2 gene mutation
  3. Ductal Carcinoma in situ (DCIS) only, and extensive DCIS
  4. Bilateral breast cancers
  5. Previous breast cancer (invasive or DCIS in either breast)
  6. Pregnancy as confirmed on blood tests or ultrasound examination
  7. Metastatic disease
  8. Any previous type of breast radiotherapy
  9. Significant other clinical risk factors and co-morbidities at the discretion of the treating clinicians
  10. Previous or concomitant malignancy except adequately treated: non-melanomatous skin cancer; in situ carcinoma of the cervix and in situ melanoma

Sites / Locations

  • Addenbrooke's Hospital
  • South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital
  • Ipswich Hospital
  • St. George's Hospital
  • Manchester University NHS Foundation Trust
  • Royal Cornwall Hospital
  • Royal Hampshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mastectomy +/- reconstruction

Therapeutic Mammoplasty

Arm Description

Either 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 (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.

Outcomes

Primary Outcome Measures

Number of women screened
Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial
Number of women eligible for the trial
Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
Consent rate
The proportion of women eligible for the trial who provide written informed consent
Compliance with trial procedures
Rate of compliance with allocated treatment and reason for deviation

Secondary Outcome Measures

Reasons why patients accept or decline randomisation
Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire)
Qualitative research (clinical staff)
Tabulation of views of clinical staff following qualitative interviews
Qualitative research (patients)
Tabulation of views of participating patients following qualitative interviews

Full Information

First Posted
March 21, 2018
Last Updated
May 17, 2021
Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03514654
Brief Title
MIAMI Safe Surgery for Multiple Breast Cancers
Acronym
MIAMI
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators will run a small study to evaluate whether a sufficient number of eligible patients can be identified and are willing to accept randomisation of the interventions in question. Recruitment and compliance rates of which will inform the feasibility and design of a larger trial. This will comprise a multi-centre randomised controlled trial in women with Multiple Ipsilateral Breast cancer (MIBC) requiring surgery. Participants will receive either Therapeutic Mammoplasty (TM) following excision of each cancer focus or mastectomy (+/- reconstruction). Patients will be randomised (1:1) into either intervention or control group.Therapeutic mammoplasty is an operation to remove breast cancer(s) whilst also significantly reducing the size of the breast. Therapeutic mammoplasty can be used to remove more than one cancer in the breast using separate lumpectomies. Both skin and breast tissue are removed, leaving scars similar to those seen after a standard breast reduction. Each patient is followed up for 12 months post treatment with a total of 50 patients recruited. Timings of the follow-up visits are aligned with standard of care practice for this patient population with quality of life questionnaires and clinical photographs completed before and after surgery. Twenty women will also be invited to an optional semi-structured interview at twelve months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Unilateral
Keywords
Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To evaluate whether a sufficient number of eligible patients can be identified and are willing to accept randomisation of the interventions in question. Recruitment and compliance rates of which will inform the feasibility and design of a larger trial
Masking
None (Open Label)
Masking Description
Neither the patients nor the clinical team will be blinded to the trial arms of this study
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mastectomy +/- reconstruction
Arm Type
Active Comparator
Arm Description
Either 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.
Arm Title
Therapeutic Mammoplasty
Arm Type
Active Comparator
Arm Description
Therapeutic 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.
Intervention Type
Procedure
Intervention Name(s)
Mastectomy
Intervention Description
Removal of the whole breast.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Mammoplasty
Intervention Description
Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.
Primary Outcome Measure Information:
Title
Number of women screened
Description
Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial
Time Frame
36 Months
Title
Number of women eligible for the trial
Description
Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
Time Frame
36 Months
Title
Consent rate
Description
The proportion of women eligible for the trial who provide written informed consent
Time Frame
36 Months
Title
Compliance with trial procedures
Description
Rate of compliance with allocated treatment and reason for deviation
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
Reasons why patients accept or decline randomisation
Description
Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire)
Time Frame
36 Months
Title
Qualitative research (clinical staff)
Description
Tabulation of views of clinical staff following qualitative interviews
Time Frame
36 Months
Title
Qualitative research (patients)
Description
Tabulation of views of participating patients following qualitative interviews
Time Frame
36 Months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study focuses on female breast cancer
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe Winters
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Facility Name
Royal Hampshire Hospital
City
Winchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
35227311
Citation
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.
Results Reference
derived

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MIAMI Safe Surgery for Multiple Breast Cancers

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