Clinical Trials /

MIAMI Safe Surgery for Multiple Breast Cancers

NCT03514654

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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.

Clinical Trial IDs

  • ORG STUDY ID: 17/0048
  • NCT ID: NCT03514654

Conditions

  • Breast Cancer, Unilateral

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Mastectomy +/- reconstructionActive ComparatorEither 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 MammoplastyActive ComparatorTherapeutic 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.

      Eligibility Criteria

              Inclusion Criteria:
      
                1. >40 years with MIBC, with the largest clinical cancer measuring 30mm as part of
                   multifocal or multicentric "disease sites". 30mm 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. Minimum of two invasive foci 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:40 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Number of women screened
      Time Frame:36 Months
      Safety Issue:
      Description:Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial

      Secondary Outcome Measures

      Measure:Reasons why patients accept or decline randomisation
      Time Frame:36 Months
      Safety Issue:
      Description:Tabulation of reasons why patients accept or decline randomisation (assessed from patient-completed Qualitative Study questionnaire)
      Measure:Qualitative research (clinical staff)
      Time Frame:36 Months
      Safety Issue:
      Description:Tabulation of views of clinical staff following qualitative interviews
      Measure:Qualitative research (patients)
      Time Frame:36 Months
      Safety Issue:
      Description:Tabulation of views of participating patients following qualitative interviews

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University College, London

      Trial Keywords

      • Breast Cancer
      • Mastectomy
      • Therapeutic Mammoplasty
      • Multiple Ipsilateral Breast Cancers

      Last Updated