Diagnosis of Pathological Complete Response by Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer

NCT02575612 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT).

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups

  As an explorative study, the statistical analysis was performed using descriptive methods only. For a baseline comparison between groups, the investigators compared the group of patients with pCR to the group of patients without pCR. As primary outcomes the investigators calculated negative predictive values (NPV) and false negative rates (FNR) for the whole study cohort as well as for certain subgroups (especially addressing the question of evaluating representativeness of VAB). The investigators calculated two-sided-95% confidence intervals for all results.

  1 week

Secondary Outcomes (1)

• negative predictive values to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups

  1 week

Study Arms (1)

vacuum-assisted biopy

EXPERIMENTAL

All patients enrolled in this study received a vacuum-assisted biopsy before surgery.

Procedure: vacuum-assisted biopsy

Interventions

vacuum-assisted biopsy PROCEDURE

Ultrasound guided VAB was used directly prior to breast conserving surgery or mastectomy. It was performed by experienced physicians (\> 50 ultrasound guided minimal invasive biopsies per year, \> 500 breast ultrasound examination of the breast per year). The needle was placed below or beside the target lesion according to physician's choice. At least six biopsies should be taken; up to 12 according to the physicians choice. After the VAB a clip marker was placed to highlight the position of the biopsy for specimen radiography and pathology.

Also known as: VAB, vacuum-assisted minimal invasive biopsy

vacuum-assisted biopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators included patients
• after neoadjuvant chemotherapy (NACT) according to the NACT protocol
• with at least one detectable mass / marker after NACT in ultrasound
• with cT1c-cT4a-c tumors
• after informed consent
• with unilateral or bilateral primary breast cancer, confirmed histologically prior to chemotherapy
• with known grading, ER/PgR/HER-2neu- and Ki-67 status
• with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
• clinical / imaging partial or complete response to NACT

You may not qualify if:

• The investigators excluded patients from the study with
• NACT \<12 weeks because of termination due to progressive disease, massive adverse events or patient wish
• non-detectable mass in ultrasound / dislocation of marker (\> 10mm distance to the initial lesion)
• cT4d stage (inflammatory breast cancer)
• M1 stages
• stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University Breast Unit, Department of Gynecology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (2)

• Pfob A, Sidey-Gibbons C, Rauch G, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Degenhardt T, Rom J, Rody A, van Mackelenbergh M, Banys-Paluchowski M, Grosse R, Reinisch M, Karsten M, Golatta M, Heil J. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery. J Clin Oncol. 2022 Jun 10;40(17):1903-1915. doi: 10.1200/JCO.21.02439. Epub 2022 Feb 2.

  PMID: 35108029 DERIVED

• Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8.

  PMID: 33307491 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Joerg Heil, Prof. Dr.

  University of Heidelberg, Department of Gynecology, Breast Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med Jörg Heil

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 14, 2015
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

DE (1)