New Techniques to evAlUate Response to neOadjuvant Treatments in bReast cAncer (AURORA) (AURORA)

March 11, 2021 updated by: Clinica Universidad de Navarra, Universidad de Navarra

New Techniques to evAlUate Response to neOadjuvant Treatments in bReast cAncer: Can Breast Surgery be Avoided

The role of neoadjuvant chemotherapy (NAC) in breast cancer is well established. Increasing rates of pathologic complete response (pCR) has increased de-escalation of surgical techniques. The objective of the study is to evaluate new radiologic techniques that can accurately detect complete response in order to eliminate breast surgery. . . Currently, there are several imaging techniques for NAC response assessment (magnetic resonance imaging -MRI-, mammography and ultrasound), with good correlation in partial response, but they lack power in predicting complete pathological response. The investigators propose to use IVIM (Intravoxel incoherent motion), Kurtosis (DKI by Diffusion Kurtosis imaging) and diffusion tensor image (DTI) in MRI, contrast enhancement mammography and shear wave elastography for the evaluation of the response to systemic treatment in breast cancer patients. In order to validate the technique, in those patients with a radiological complete response by all the radiological imaging methods, a vacuum-assisted biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen. So the investigators can evaluate if patients with complete radiological response after NAC, can be spared breast surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The role of neoadjuvant chemotherapy (NAC) in breast cancer is well established. In inoperable patients at the time of diagnosis, the goal of NAC is to achieve a pathologic complete response (pCR) which has shown that it improves disease-free survival when compared to those cases with residual tumoral cells. Detection of the presence of residual disease is crucial for surgical planning; the ultimate goal would be to avoid surgery in those patients who achieve a pCR, though nowadays validated techniques with power enough to detect this residual disease are lacking.

Currently, several imaging techniques for NAC response assessment are being used (magnetic resonance imaging -MRI-, mammography and ultrasound), with good correlation in partial response, but they lack power in predicting complete pathological response; among them, nowadays the most accurate is MRI. In recent years, the use of the diffusion-enhanced images have been proposed for the quantitative characterization and for helping to improve the specificity of dynamic contrast study.

The investigators propose to use a bi-exponential model, IVIM (Intravoxel incoherent motion), which differentiates between microperfusion used by microvascular blood flow from the diffusion of water. Kurtosis (DKI by Diffusion Kurtosis imaging) which quantifies the deviation from the Gaussian pattern and diffusion tensor image (DTI) which provides information on the microstructure and pathophysiology tumor, presenting a statistically significant relationship with tumor cellularity. Preliminary studies have reported promising results for the evaluation of the early response to systemic treatment in breast cancer patients. Its utility for NAC response assessment in these patients will be analysed.

Recent studies have evaluated the application of contrast mammography in the assessment of the response to NAC, with MRI-like results. It is a faster and cheaper technique compared to MRI radiological evaluation of the response after NAC through this technique will be assessed and compared its results with the different techniques used in previous studies / in daily practice.

Shear wave elastography is a very useful tool for the quantitative assessment of the tissue hardness that is widely used for differentiating benign lesions from malignant ones. Nowadays some studies are investigating its usefulness in the assessment of the radiological evaluation after NAC, with promising results in terms of early evaluation. In this study, the elastography will be performed on pre surgical evaluation and its correlation with pathological anatomy.

In order to validate the technique, in those patients with a radiological complete response by all the radiological imaging methods, a stereotactic biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen. If the false negative rate of the presurgical assessment including the biopsy are below 5%, patients could spare surgery when there is a complete radiological response. Objectives :

To evaluate if patients with complete radiological response after NAC, in this setting can be spared breast surgery. . - To determine if IVIM, KURTOSIS or DTI diffusion sequences in MRI can assess the response to NAC better than conventional sequences and, thus, be able to avoid the use of intravenous contrast in the MRI study in the future. - To determine whether the study of breast elastography with shear wave technology, is more sensitive or specific in the detection of residual tumor after NAC in breast cancer. - To determining whether contrast enhanced mammography helps us to assess the response to NAC in breast cancer, compared to MRI standard practice.

The expected results are:

False negative rate of pre-surgery biopsy <5%. Achieve a sensitivity >80% for the radiological tests in predicting pCR for selected tumoral subtypes (Triple Negative and HER2 enriched tumors).

Noninferiority of contrast mammography compared to breast MRI in determining the response to NAC.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carolina Sobrido, MD, PhD
  • Phone Number: 6022 +34948296666
  • Email: csobrido@unav.es

Study Locations

  • Spain
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Carolina Sobrido, MD, PhD
          • Phone Number: 6022 +34948296666
          • Email: csobrido@unav.es
        • Principal Investigator:
          • Carolina Sobrido, MD, PhD
        • Principal Investigator:
          • Isabel T Rubio, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with Pathologic diagnosis of breast cancer with indication of neoadjuvant chemotherapy

Exclusion Criteria:

  • Breast cancer recurrence
  • Other synchronic tumour.
  • Inflammatory cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAC Patients.
Breast cancer patients after NAC completion, prior to surgery
Procedure: Vacuum-assisted breast biopsy
In those patients with a radiological complete response by all the radiological imaging methods, a stereotactic biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Radiological Response
Time Frame: 6 months after NAC initiation
To evaluate if patients with complete radiological response after NAC, in this setting can be spared breast surgery.
6 months after NAC initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Measurements
Time Frame: 6 months after NAC initiation
To determine if IVIM, KURTOSIS or DTI diffusion sequences in MRI can assess the response to NAC better than conventional sequences and, thus, be able to avoid the use of intravenous contrast in the MRI study in the future.
6 months after NAC initiation
Elastography
Time Frame: 6 months after NAC initiation
To determine whether the study of breast elastography with shear wave technology, is more sensitive or specific in the detection of residual tumor after NAC in breast cancer.
6 months after NAC initiation
MRI Comparison
Time Frame: 6 months after NAC initiation
To determining whether contrast enhanced mammography helps us to assess the response to NAC in breast cancer, compared to MRI standard practice.
6 months after NAC initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AURORA (Other Identifier: Mayo Clinic)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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