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

NCT04795349 | Unknown

• 1 other identifier: AURORA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Neoadjuvant chemotherapy; Magnetic Resonance Imaging; Contrast mammography; Elastography

Outcome Measures

Primary Outcomes (1)

• Complete Radiological Response

  To evaluate if patients with complete radiological response after NAC, in this setting can be spared breast surgery.

  6 months after NAC initiation

Secondary Outcomes (3)

• MRI Measurements

  6 months after NAC initiation

• Elastography

  6 months after NAC initiation

• MRI Comparison

  6 months after NAC initiation

Study Arms (1)

NAC Patients.

EXPERIMENTAL

Breast cancer patients after NAC completion, prior to surgery

Procedure: Vacuum-assisted breast biopsy

Interventions

Vacuum-assisted breast biopsy PROCEDURE

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.

NAC Patients.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra

Madrid, 28027, Spain

RECRUITING

Related Publications (6)

• Heil J, Kuerer HM, Pfob A, Rauch G, Sinn HP, Golatta M, Liefers GJ, Vrancken Peeters MJ. Eliminating the breast cancer surgery paradigm after neoadjuvant systemic therapy: current evidence and future challenges. Ann Oncol. 2020 Jan;31(1):61-71. doi: 10.1016/j.annonc.2019.10.012.

  PMID: 31912797 BACKGROUND

• Croshaw R, Shapiro-Wright H, Svensson E, Erb K, Julian T. Accuracy of clinical examination, digital mammogram, ultrasound, and MRI in determining postneoadjuvant pathologic tumor response in operable breast cancer patients. Ann Surg Oncol. 2011 Oct;18(11):3160-3. doi: 10.1245/s10434-011-1919-5. Epub 2011 Sep 27.

  PMID: 21947594 BACKGROUND

• Marinovich ML, Houssami N, Macaskill P, Sardanelli F, Irwig L, Mamounas EP, von Minckwitz G, Brennan ME, Ciatto S. Meta-analysis of magnetic resonance imaging in detecting residual breast cancer after neoadjuvant therapy. J Natl Cancer Inst. 2013 Mar 6;105(5):321-33. doi: 10.1093/jnci/djs528. Epub 2013 Jan 7.

  PMID: 23297042 BACKGROUND

• Sun K, Chen X, Chai W, Fei X, Fu C, Yan X, Zhan Y, Chen K, Shen K, Yan F. Breast Cancer: Diffusion Kurtosis MR Imaging-Diagnostic Accuracy and Correlation with Clinical-Pathologic Factors. Radiology. 2015 Oct;277(1):46-55. doi: 10.1148/radiol.15141625. Epub 2015 May 4.

  PMID: 25938679 BACKGROUND

• Furman-Haran E, Nissan N, Ricart-Selma V, Martinez-Rubio C, Degani H, Camps-Herrero J. Quantitative evaluation of breast cancer response to neoadjuvant chemotherapy by diffusion tensor imaging: Initial results. J Magn Reson Imaging. 2018 Apr;47(4):1080-1090. doi: 10.1002/jmri.25855. Epub 2017 Sep 13.

  PMID: 28901594 BACKGROUND

• Katyan A, Mittal MK, Mani C, Mandal AK. Strain wave elastography in response assessment to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. Br J Radiol. 2019 Jul;92(1099):20180515. doi: 10.1259/bjr.20180515. Epub 2019 May 16.

  PMID: 31045431 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carolina Sobrido, MD, PhD

CONTACT

+34948296666; csobrido@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 12, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-02

Locations

ES (1)