Breast Cancer, UnilateralMIAMINCT03514654
MIAMI Safe Surgery for Multiple Breast Cancers
A study testing Mastectomy and Therapeutic Mammoplasty in people with Breast Cancer, Unilateral, run by University College, London at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Unilateral
- What is being tested?
- Mastectomy and Therapeutic Mammoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 1 Nov 2017to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Addenbrooke's Hospital
Cambridge
South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital
Glasgow
Ipswich Hospital
Ipswich
St. George's Hospital
London
Manchester University NHS Foundation Trust
Manchester
Royal Cornwall Hospital
Truro
Royal Hampshire Hospital
Winchester
About this study
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.
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.
Read the 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.
- Conditions
- Breast Cancer, Unilateral
- Being tested
- Mastectomy, Therapeutic Mammoplasty
- Keywords
- Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers
- Medical subject headings
- Unilateral Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Removal of the whole breast.
Therapeutic MammoplastyProcedure or surgery
Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Mastectomy +/- reconstruction | Active comparator | 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. Receives: Procedure: Mastectomy |
| Therapeutic Mammoplasty | Active comparator | 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. Receives: Procedure: Therapeutic Mammoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women screened
Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial
Measured: 36 Months
Number of women eligible for the trial
Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
Measured: 36 Months
Consent rate
The proportion of women eligible for the trial who provide written informed consent
Measured: 36 Months
Compliance with trial procedures
Rate of compliance with allocated treatment and reason for deviation
Measured: 36 Months
Secondary outcomes (3)
Reasons why patients accept or decline randomisation
Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire)
Measured: 36 Months
Qualitative research (clinical staff)
Tabulation of views of clinical staff following qualitative interviews
Measured: 36 Months
Qualitative research (patients)
Tabulation of views of participating patients following qualitative interviews
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, UnilateralStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Zoe Winters, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514654
- Sponsor's protocol ID
- 17/0048
- Acronym
- MIAMI
- Status last verified
- May 2021
- First submitted
- 21 Mar 2018
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35227311
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03514654
- Acronym / sponsor ID
- MIAMI / 17/0048
- Conditions
- Breast Cancer, Unilateral
- Keywords
- Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mastectomy +/- reconstruction | Active comparator | Procedure: MastectomyEither 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 comparator | Procedure: Therapeutic MammoplastyTherapeutic 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MastectomyRemoval of the whole breast. | Procedure or surgery | Mastectomy +/- reconstruction |
| Therapeutic MammoplastyExcision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes. | Procedure or surgery | Therapeutic Mammoplasty |
Primary outcome
Number of women screened
Time frame: 36 Months
Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial
Number of women eligible for the trial
Time frame: 36 Months
Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
Consent rate
Time frame: 36 Months
The proportion of women eligible for the trial who provide written informed consent
Compliance with trial procedures
Time frame: 36 Months
Rate of compliance with allocated treatment and reason for deviation
3 secondary outcomes
Reasons why patients accept or decline randomisation
Time frame: 36 Months
Qualitative research (clinical staff)
Time frame: 36 Months
Qualitative research (patients)
Time frame: 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 35227311Ingram 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoe Winters principal investigator
University College, London
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastectomy and Therapeutic Mammoplasty in people with Breast Cancer, Unilateral, run by University College, London at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women screened (time frame: 36 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.