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

NCT ID: NCT02575612

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-02-28

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).

Detailed Description

Neoadjuvant chemotherapy (NACT) is an increasingly used approach for patients with locally advanced and primarily inoperable breast cancer or for patients with potentially chemosensitive tumors. In clinical routine surgical treatment follows the pre-operative chemotherapy. However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future.

Up to now, prediction of pCR after NACT, i.e. diagnosing a pCR without surgery, is based on tumor biology at diagnosis, the applied NACT regimen and breast imaging results; all with mediocre accuracy. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.

From September 1st, 2014 to February 15th, 2015 the investigators performed ultrasound guided vacuum-assisted minimal invasive biopsy (VAB) on 50 breast cancer patients after NACT and directly prior to surgery. To analyse VAB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

vacuum-assisted biopy

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

Group Type: EXPERIMENTAL

vacuum-assisted biopsy

Intervention Type: 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.

Interventions

vacuum-assisted biopsy

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.

Intervention Type: PROCEDURE

Other Intervention Names

VAB; vacuum-assisted minimal invasive biopsy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Jörg Heil

Prof. Dr. med Jörg Heil

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joerg Heil, Prof. Dr.

Role: STUDY_CHAIR

University of Heidelberg, Department of Gynecology, Breast Unit

Locations

University Breast Unit, Department of Gynecology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35108029 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33307491 (View on PubMed)

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id