MIAMI Safe Surgery for Multiple Breast Cancers (MIAMI)
Breast Cancer, Unilateral
About this trial
This is an interventional treatment trial for Breast Cancer, Unilateral focused on measuring Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers
Eligibility Criteria
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
Sites / Locations
- Addenbrooke's Hospital
- South Glasgow Hospitals - New Victoria Hospital / Gartnavel General Hospital
- Ipswich Hospital
- St. George's Hospital
- Manchester University NHS Foundation Trust
- Royal Cornwall Hospital
- Royal Hampshire Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Mastectomy +/- reconstruction
Therapeutic Mammoplasty
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 (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.