Breast Cancer, Unilateral Clinical Trial
— MIAMIOfficial 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.
| Verified date | May 2021 |
| Source | University College, London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | October 31, 2020 |
| Est. primary completion date | October 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 40 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| 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 | Royal Hampshire Hospital | Winchester |
| Lead Sponsor | Collaborator |
|---|---|
| University College, London | National Institute for Health Research, United Kingdom |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of women screened | Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial | 36 Months | |
| Primary | Number of women eligible for the trial | Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty | 36 Months | |
| Primary | Consent rate | The proportion of women eligible for the trial who provide written informed consent | 36 Months | |
| Primary | Compliance with trial procedures | Rate of compliance with allocated treatment and reason for deviation | 36 Months | |
| Secondary | 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 | |
| Secondary | Qualitative research (clinical staff) | Tabulation of views of clinical staff following qualitative interviews | 36 Months | |
| Secondary | Qualitative research (patients) | Tabulation of views of participating patients following qualitative interviews | 36 Months |