MIAMI Safe Surgery for Multiple Breast Cancers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Breast Cancer, Unilateral

Intervention / Treatment
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* Procedure: Mastectomy
* Procedure: Therapeutic Mammoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mastectomy +/- reconstruction<br>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<br>* Removal of the whole breast.<br>|
| Active Comparator: Therapeutic Mammoplasty<br>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<br>* Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons why patients accept or decline randomisation | Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire) | 36 Months | 
| Qualitative research (clinical staff) | Tabulation of views of clinical staff following qualitative interviews | 36 Months | 
| Qualitative research (patients) | Tabulation of views of participating patients following qualitative interviews | 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers