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

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ClinicalTrials.gov Identifier: NCT04795349
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Vacuum-assisted breast biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Techniques to evAlUate Response to neOadjuvant Treatments in bReast cAncer: Can Breast Surgery be Avoided
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795349


Contacts
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Contact: Carolina Sobrido, MD, PhD +34948296666 ext 6022 csobrido@unav.es

Locations
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Spain
Clínica Universidad de Navarra Recruiting
Madrid, Spain, 28027
Contact: Carolina Sobrido, MD, PhD    +34948296666 ext 6022    csobrido@unav.es   
Principal Investigator: Carolina Sobrido, MD, PhD         
Principal Investigator: Isabel T Rubio, MD, PhD         
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Publications:

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT04795349    
Other Study ID Numbers: AURORA
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Breast cancer
Neoadjuvant chemotherapy
Magnetic Resonance Imaging
Contrast mammography
Elastography
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases