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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mastectomy | Procedure | Removal of the whole breast. |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Study focuses on female breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Zoe Winters | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrooke's Hospital | Cambridge | United Kingdom | ||||
| South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35227311 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D000069584 | Unilateral Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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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
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Neither the patients nor the clinical team will be blinded to the trial arms of this study
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| Therapeutic Mammoplasty |
| Procedure |
Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes. |
|
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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |