MIAMI Safe Surgery for Multiple Breast Cancers

Not Applicable

Completed

• Conditions: Breast Cancer, Unilateral
• Interventions: Procedure: Therapeutic Mammoplasty; Procedure: Mastectomy

• Registration Number: NCT03514654
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-05-02
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Mammoplasty	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.
Mastectomy +/- reconstruction	Mastectomy	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.

Primary Outcome Measures

Name	Time	Method
Number of women eligible for the trial	36 Months	Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
Number of women screened	36 Months	Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial
Consent rate	36 Months	The proportion of women eligible for the trial who provide written informed consent
Compliance with trial procedures	36 Months	Rate of compliance with allocated treatment and reason for deviation

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Royal Hampshire Hospital; 🇬🇧 Winchester, United Kingdom

South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital; 🇬🇧 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