Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy

NCT ID: NCT04468113

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 339 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2023-07-30

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 of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip) before the start of NST in order to safely identify and localize a clip and (former) tumor bed after completion of NST. Reliable sonographic detection of the clip would be preferred to mammography-guided detection and marking. In addition to avoiding radiation exposure by mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire marking of the clip is less painful for the patient than stereotactic wire marking.

The present prospective registry study aims to evaluate how often the intramammary Tumark® Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with mammographic (stereotactic) guidance can be avoided.

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 suspicious lesion is performed after ultrasound-guided core biopsy or mammography-guided vacuum biopsy. Clipping is necessary to enable the clear identification of the sonographically suspicious area of the breast and safe surgical removal of the remaining tumor tissue (if any) during a later surgery, even following a good response under NST. The placement of a marker (clip) is particularly important for the precise localization of the original tumor bed in patients with pCR.

There are a number of commercially available markers (clips) which are indicated for intramammary marking of a lesion and which differ in terms of shape and material. Difficulties may arise in placing the clip in the tumor or the tumor center. In addition, the clip can dislocate from the initial location and/or the clip might not be visualized during response monitoring. Evaluations of the ultrasound-visible clip made of nitinol investigated in this study showed very good results regarding marker dislocation and visibility within 7 days after inital placement.The clip, which immediately unfolds into a 3-dimensional spherical structure after insertion into the tissue, could be detected by both sonography and mammography in all 50 cases after the intervention; however, long-term data data at follow-up controls during and after NST are not available so far.

According to current German guidelines, imaging-assisted wire marking is recommended without restriction before breast conserving surgery for non-palpable lesions. The clip is considered the target lesion for wire marking, which can be done under sonographic or stereotactic control. If the clip is reliably visible on ultrasound (even in patients with pCR), the stereotactic control of wire marking can be omitted. Therefore, the ability to visualize a clip in breast ultrasonography is of great importance.

The present multicenter study aims to evaluate the sonographic detection rate of the intramammary Tumark® Vision clips after NST in clinical routine and the proportion of cases in which the clip cannot be detected, and thus the rate of mammography-guided wire markings.

Conditions

Primary Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

US-guided core biopsy and clip placement

Female patients with sonographically suspicious, intramammary foci, scheduled for ultrasound-guided core biopsy and marking of the lesion with the Tumark® Vision Clip

Tumark® Vision clip

Intervention Type: DEVICE

Suspicious intramammary lesion is marked with clip

Interventions

Tumark® Vision clip

Suspicious intramammary lesion is marked with clip

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kliniken Essen-Mitte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherko Kuemmel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany

Mattea Reinisch, MD

Role: STUDY_CHAIR

Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany

Jörg Heil, MD, PhD

Role: STUDY_CHAIR

Department of Gynecology, Breast Center, Heidelberg University, Germany

Locations

Interdisciplinary Breast Unit, Kliniken Essen-Mitte

Essen, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

V2_16-04-2020

Identifier Type: -

Identifier Source: org_study_id