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

NCT04468113 | Completed DMC

• 1 other identifier: V2_16-04-2020
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Breast Cancer

Keywords

breast cancer; clip; ultrasound; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Sonographic detection rate of clip at the time of surgery after completion of NST

  Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment

  At the time of surgery

Secondary Outcomes (14)

• Number of ultrasound-guided clip placements per patient

  Immediately after placement of clip

• Rate of successful clip placements in the tumor center

  Immediately after placement of clip

• Visibility of the device (Tumark® Vision) cannula

  During placement of clip

• Complications associated with the application of the clip

  Up to 6 months after placement of clip

• Sonographic detection rate of clips in patients receiving NST

  Immediately after placement of clip as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively

Study Arms (1)

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

Device: Tumark® Vision clip

Interventions

Tumark® Vision clip DEVICE

Suspicious intramammary lesion is marked with clip

US-guided core biopsy and clip placement

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with a suspicious intramammary lesion in the breast are identified as female during presentation in the clinic according to their health insurance ID card.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients with sonographically suspicious unilateral or bilateral intramammary foci, scheduled for sonography-guided core biopsy and marking of the lesion with the Tumark® Vision Clip.

You may qualify if:

• 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
• 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

You may not qualify if:

• allergy to titanium and/or nickel
• pregnancy
• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead

Study Sites (1)

Interdisciplinary Breast Unit, Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Related Publications (4)

• Ruland AM, Hagemann F, Reinisch M, Holtschmidt J, Kummel A, Dittmer-Grabowski C, Stoblen F, Rotthaus H, Dreesmann V, Blohmer JU, Kummel S. Using a New Marker Clip System in Breast Cancer: Tumark Vision(R) Clip - Feasibility Testing in Everyday Clinical Practice. Breast Care (Basel). 2018 Apr;13(2):116-120. doi: 10.1159/000486388. Epub 2018 Mar 9.

  PMID: 29887788 BACKGROUND

• Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.

  PMID: 29175149 BACKGROUND

• von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.

  PMID: 22508812 BACKGROUND

• Shah AD, Mehta AK, Talati N, Brem R, Margolies LR. Breast tissue markers: Why? What's out there? How do I choose? Clin Imaging. 2018 Nov-Dec;52:123-136. doi: 10.1016/j.clinimag.2018.07.003. Epub 2018 Jul 6.

  PMID: 30059952 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin fixed tissue from routine histopathology assessment

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sherko Kuemmel, MD, PhD

  Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany

  PRINCIPAL INVESTIGATOR

• Mattea Reinisch, MD

  Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany

  STUDY CHAIR

• Jörg Heil, MD, PhD

  Department of Gynecology, Breast Center, Heidelberg University, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 13, 2020
• Study Start: May 14, 2020
• Primary Completion: March 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)