Liquid Biopsies and Imaging in Breast Cancer

NCT04223492 | Completed

• 1 other identifier: 19-396
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to show proof of concept for combining multi-parametric MRI with liquid biopsies in addition to conventional clinical and pathologic information, to accurately predict response to neoadjuvant treatment for patients with primary breast cancer.

Conditions

Breast Cancer

Keywords

Breast Cancer; Neoadjuvant; Response Prediction; Liquid Biopsies; Magnetic resonance imaging; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• Residual Cancer Burden index in surgical resection specimen

  The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

  After neoadjuvant treatment and surgery (approx. 6 months from diagnosis)

Secondary Outcomes (2)

• Radiological lesion volume on DCE MRI after NAC

  After neoadjuvant treatment (approx. 6 months from diagnosis)

• pathological complete response, defined as ypT0/ypN0

  After neoadjuvant treatment and surgery (approx. 6 months from diagnosis)

Study Arms (1)

Neoadjuvant systemic treatment

OTHER

All patients undergo standard neoadjuvant treatment and additional multi-parametric MRI and liquid biopsies during neoadjuvant treatment.

Diagnostic Test: Liquid biopsy; Diagnostic Test: Multi-parametric MRI

Interventions

Liquid biopsy DIAGNOSTIC_TEST

A blood sample containing circulating tumor DNA and circulating tumor cells.

Neoadjuvant systemic treatment

Multi-parametric MRI DIAGNOSTIC_TEST

Multi-parametric MRI combines different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology.

Neoadjuvant systemic treatment

Eligibility Criteria

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

You may qualify if:

• Histologically proven invasive breast carcinoma
• Planned for neoadjuvant chemotherapy (and in case of a Her2-positive tumor: addition of trastuzumab and/or pertuzumab)

You may not qualify if:

• Luminal A breast cancer (defined as: ER-positive and HER2-negative by immunohistochemistry and Bloom and Richardson grade 1 or 2)
• Inflammatory breast cancer
• Distant metastases on PET/CT
• Other active malignant disease in the past 5 years (excluded squamous cell or basal cell carcinoma of the skin)
• Pregnant or lactating women
• Contra-indications for MRI according to standard hospital guidelines
• Contra-indications for gadolinium-based contrast-agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR \< 30 mL/min/1.73m2

Sponsors & Collaborators

• UMC Utrecht: lead
• Horizon 2020 - European Commission: collaborator
• Philips Electronics Nederland BV: collaborator
• Agena Bioscience GmbH: collaborator
• DiaDx: collaborator
• Stilla Technologies: collaborator
• ANGLE Europe Limited: collaborator
• ALS Automated Lab Solutions GmbH: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Philips GmbH Innovate Technologies: collaborator
• Institut du Cancer de Montpellier - Val d'Aurelle: collaborator

Study Sites (1)

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• Janssen LM, Suelmann BBM, Elias SG, Janse MHA, van Diest PJ, van der Wall E, Gilhuijs KGA. Improving prediction of response to neoadjuvant treatment in patients with breast cancer by combining liquid biopsies with multiparametric MRI: protocol of the LIMA study - a multicentre prospective observational cohort study. BMJ Open. 2022 Sep 20;12(9):e061334. doi: 10.1136/bmjopen-2022-061334.

  PMID: 36127090 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Liquid Biopsy; Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Magnetic Resonance Imaging; Tomography; Diagnostic Imaging

Study Officials

• Kenneth GA Gilhuijs, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 10, 2020
• Study Start: January 2, 2019
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 2 years after the LIMA Project has ended (and the LIMA breast cancer trial thus has been closed by the IRB)
• Access Criteria: Any reasonable request compliant with patient consent will be granted.

Locations

NL (1)