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MIAMI Safe Surgery for Multiple Breast Cancers (MIAMI)

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ClinicalTrials.gov Identifier: NCT03514654
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Breast Cancer, Unilateral Procedure: Mastectomy Procedure: Therapeutic Mammoplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
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.
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mastectomy +/- reconstruction
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.
Procedure: Mastectomy
Removal of the whole breast.

Active Comparator: Therapeutic Mammoplasty
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.
Procedure: Therapeutic Mammoplasty
Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.




Primary Outcome Measures :
  1. 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

  2. Number of women eligible for the trial [ Time Frame: 36 Months ]
    Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty

  3. Consent rate [ Time Frame: 36 Months ]
    The proportion of women eligible for the trial who provide written informed consent

  4. Compliance with trial procedures [ Time Frame: 36 Months ]
    Rate of compliance with allocated treatment and reason for deviation


Secondary Outcome Measures :
  1. Reasons why patients accept or decline randomisation [ Time Frame: 36 Months ]
    Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire)

  2. Qualitative research (clinical staff) [ Time Frame: 36 Months ]
    Tabulation of views of clinical staff following qualitative interviews

  3. Qualitative research (patients) [ Time Frame: 36 Months ]
    Tabulation of views of participating patients following qualitative interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study focuses on female breast cancer
Accepts Healthy Volunteers:   No
Criteria

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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514654


Contacts
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Contact: Nick Roberts 02076799280 SITU.MIAMI@ucl.ac.uk
Contact: Norman Williams, PhD 02076799280 norman.williams@ucl.ac.uk

Locations
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United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Contact: John Benson         
Derby & Burton Teaching Hospitals Recruiting
Derby, United Kingdom
Contact: Amtul Carmichael         
Doncaster and Bassetlaw Hospitals NHS Foundation Trust Recruiting
Doncaster, United Kingdom, DN2 5LT
Contact: Lynda Wyld         
Principal Investigator: Lynda Wyld         
Frimley Park Hospital Recruiting
Frimley, United Kingdom
Contact: Hisham Osman         
South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital Recruiting
Glasgow, United Kingdom
Contact: Sheila Stallard         
Ipswich Hospital Recruiting
Ipswich, United Kingdom
Contact: Caroline Mortimer         
Principal Investigator: Caroline Mortimer         
St. George's Hospital Recruiting
London, United Kingdom
Contact: Sarah Tang         
Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: James Harvey         
Wexham Park Hospital Recruiting
Slough, United Kingdom
Contact: Alexandra Tenovici         
Great Western Hospital Recruiting
Swindon, United Kingdom
Contact: Anushka Chaudhry         
Royal Cornwall Hospital Recruiting
Truro, United Kingdom
Contact: Philip Drew         
Principal Investigator: Philip Drew         
Royal Hampshire Hospital Recruiting
Winchester, United Kingdom
Contact: Siobhan Laws         
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Zoe Winters University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03514654     History of Changes
Other Study ID Numbers: 17/0048
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Breast Cancer
Mastectomy
Therapeutic Mammoplasty
Multiple Ipsilateral Breast Cancers
Additional relevant MeSH terms:
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Breast Neoplasms
Unilateral Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases