Status:
COMPLETED
Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy
Lead Sponsor:
Kliniken Essen-Mitte
Conditions:
Primary Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use o...
Detailed Description
Breast cancer patients whose carcinomas have an aggressive tumor biology which implies the need for chemotherapy are increasingly being treated with NST. As a standard procedure, clip placement of the...
Eligibility Criteria
Inclusion
- female patient aged ≥ 18 years
- written informed consent
- patient's consent to NST
- suspicious unilateral or bilateral intramammary foci that can be safely identified by ultrasound
- no evidence of distant metastasis (complete staging does not have to be present at inclusion)
- indication for breast conserving therapy
- no prior clip placement in the confirmed intramammary carcinoma
- patient is able to undergo NST treatment (even if the indication based on tumor biology is not yet available)
- high compliance and high number of planned relevant surgical interventions in participating study center
- patient can understand the scope of this prospective registry study
Exclusion
- allergy to titanium and/or nickel
- pregnancy
- ipsilateral relapse (when NST: no exclusion criterion)
- prior extensive breast surgery (starting from quadrant resection)
- inflammatory breast cancer
- extramammary breast cancer
- multicentric or multifocal breast cancer
- patient is not operable
- patient is already undergoing adjuvant/neoadjuvant therapy
- inability to understand the purpose of the clinical trial or to comply with study procedures
Key Trial Info
Start Date :
May 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT04468113
Start Date
May 14 2020
End Date
July 30 2023
Last Update
November 24 2023
Active Locations (1)
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1
Interdisciplinary Breast Unit, Kliniken Essen-Mitte
Essen, Germany, 45136