Breast Cancer, Unilateral
Conditions
Keywords
Breast Cancer, Mastectomy, Therapeutic Mammoplasty, Multiple Ipsilateral Breast Cancers
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.
Interventions
PROCEDUREMastectomy
Removal of the whole breast.
PROCEDURETherapeutic Mammoplasty
Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.
Sponsors
National Institute for Health Research, United Kingdom
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Neither the patients nor the clinical team will be blinded to the trial arms of this study
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
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with trial procedures | 36 Months | Rate of compliance with allocated treatment and reason for deviation |
| Number of women screened | 36 Months | Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial |
| Number of women eligible for the trial | 36 Months | Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty |
| Consent rate | 36 Months | The proportion of women eligible for the trial who provide written informed consent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
United Kingdom
Outcome results
None listed