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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- Number of women screened
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Neither the patients nor the clinical team will be blinded to the trial arms of this study
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •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
结局指标
主要结局
Number of women screened
时间窗: 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
时间窗: 36 Months
Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty
Consent rate
时间窗: 36 Months
The proportion of women eligible for the trial who provide written informed consent
Compliance with trial procedures
时间窗: 36 Months
Rate of compliance with allocated treatment and reason for deviation
次要结局
- Reasons why patients accept or decline randomisation(36 Months)
- Qualitative research (clinical staff)(36 Months)
- Qualitative research (patients)(36 Months)