Clinical trial NCT03514654: MIAMI Safe Surgery for Multiple Breast Cancers
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer, Unilateral
Keywords: Breast Cancer
Mastectomy
Therapeutic Mammoplasty
Multiple Ipsilateral Breast Cancers
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2018-05-02
Enrollment: 4
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility 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. 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

Primary outcomes:
measure: Number of women screened
timeFrame: 36 Months
measure: Number of women eligible for the trial
timeFrame: 36 Months
measure: Consent rate
timeFrame: 36 Months
measure: Compliance with trial procedures
timeFrame: 36 Months
Secondary outcomes:
measure: Reasons why patients accept or decline randomisation
timeFrame: 36 Months
measure: Qualitative research (clinical staff)
timeFrame: 36 Months
measure: Qualitative research (patients)
timeFrame: 36 Months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Winchester
country: United Kingdom
facility: Royal Hampshire Hospital
Study officials:
affiliation: University College, London
name: Zoe Winters
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.