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Understanding genetic changes in metastatic breast cancer

AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.

Not applicable Interventional Breast International Group · NCT02102165

This study is trying to find out how genetic changes in metastatic breast cancer affect treatment responses by collecting samples from patients who have recently been diagnosed or relapsed.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorBreast International Group Academic / other
Locations52 sites (Brussels and 51 other locations)
Trial IDNCT02102165 on ClinicalTrials.gov

What this trial studies

This program aims to recruit 1300 patients with metastatic breast cancer from various hospitals across Europe. Eligible participants are adults who have recently been diagnosed with metastatic disease or have experienced a relapse, and have received no more than one prior treatment. The study involves collecting biopsy samples from both primary and metastatic tumors, as well as blood samples, for central analysis and future research. The goal is to identify genetic aberrations and understand the mechanisms of therapy response or resistance to personalize treatment for each patient.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with newly diagnosed or relapsed metastatic breast cancer who have received no more than one line of systemic therapy.

Not a fit: Patients with early-stage breast cancer or those who have received multiple lines of treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to more effective, personalized therapies for patients with metastatic breast cancer.

How similar studies have performed: Other studies focusing on genetic profiling in metastatic breast cancer have shown promise, indicating that this approach could yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Female or male ≥ 18 years with diagnosis of locally recurrent/advanced BC not amenable to treatment with curative intent or MBC who have not received more than 1 line of systemic therapy (any type) in the metastatic setting.

   Under protocol 4.0, eligible patients will be limited to locally recurrent/advanced breast cancer not amenable to treatment with curative intent or MBC with:
   * histopathology-confirmed TNBC as defined by ER \<1% and HER2 negative following ASCO-CAP guidelines
   * ILC (either based on ILC morphology or negative E-cadherin expression confirmed by IHC). Mixed ILC/invasive ductal carcinoma are not eligible for the ILC cohort.
   * late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse \> 10 years from the primary BC diagnosis.
2. Written informed consent prior to registration into the program.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
4. Availability of primary tumor tissue for research purposes.
5. Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.

   1. Up until protocol 3.0, up to 100 patients with bone-only metastasis have been included without a metastatic biopsy, if plasma samples have been collected at screening, and if the patient met all other eligibility criteria.
   2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.
   3. Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.
6. The biopsy of the metastatic lesion must be conducted either at the initial diagnosis of the BC relapse before the initiation of 1st line systemic therapy or at the 1st disease progression before initiation of a second line systemic treatment. There is no restriction in the type of therapeutic modality considered as 1st line systemic treatment, which can consist of any type of treatment administered after the diagnosis of the advanced BC relapse till the 1st disease progression thereafter.
7. Biopsies obtained during routine clinical practice are accepted if both formalin-fixed paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently from the same metastatic lesion and if collected at the pre-specified timelines for AURORA.
8. Availability of a whole blood, serum and plasma samples collected at the time of screening.
9. Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.

Exclusion Criteria:

1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting.
2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.
3. Presence of severe hematopoietic, renal, and/or hepatic dysfunction, including but not restricted to albumin \< 3 g/dl.
4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.
5. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.

Where this trial is running

Brussels and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Breast CancerAurorabreast cancermetastaticmolecular screeningtargeted gene sequencingmolecular aberrationsexploratory
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.