Breastcancer Clinical Trial
Official title:
Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.
Rationale: In the Netherlands, ≥7000 women are operated for small breast cancers yearly. In
this study, we will evaluate under which conditions it is possible to excise small breast
cancers using the Breast Lesion Excision System (BLES) under ultrasound (US) guidance. When
successful, this will allow ambulatory treatment of women with small breast cancers,
improving the cosmetic outcome and quality of life.
Objective: Our study aim is to assess whether it is feasible to remove small breast cancers
completely using the BLES system under US guidance.
Study design: This is a multi-centre, translational clinical phase II study in 125 women with
cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more
extensive disease (e.g. microcalcifications).
Study population: Women with cancers ≤1.5 cm based upon US measurements, if there is no
mammographic evidence of more extensive disease (e.g. microcalcifications or extensive
architectural distortion), and the tumor lies ≥6 mm away from the dermis, nipple or pectoral
muscle, are eligible for this study.
Intervention: In 125 women with cancers ≤1.5 cm based upon US measurements, and without
mammographic evidence of more extensive disease (e.g. microcalcifications), we will conduct
additional preoperative breast MRI to ascertain lesion size, after informed consent has been
obtained. If the lesion is confirmed ≤1.5 cm on MRI and lying ≥6 mm away from the dermis,
nipple and pectoral muscle, the patient is eligible. Moreover, patients will be asked to fill
out the questionnaire, detailing their risk profile and comorbidity index.
Under general anaesthesia for the normal surgical procedure, the tumor is first removed using
the BLES system under US guidance, through a small skin incision (<1 cm). Next, the normal
surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of
surrounding tissue, also guided by the US appearance after the BLES procedure. Margin
assessment will be performed separately for the BLES excision and the surgical specimen of
the surrounding tissue.
Main study parameters/endpoints: Main endpoint of the study is the frequency of successful
complete tumor excision by the BLES system, where successful is defined as 'having tumor free
margins, and no residual (in situ) cancer in the surgical specimen'.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Our approach allows to test the feasibility of this highly innovating approach
to remove breast cancer, with minimal negative effects or possible complications.
While there is no direct benefit nor detrimental effect from this study to the patients
participating, the study has large implications for many women, as breast cancer remains the
most common cancer in women, and due to screening, most cancers are small. Further reduction
of the impact of local treatment is still desired as the psychosocial and somatic effects of
breast deformation can be substantial.
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