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

  • STATUS
    Recruiting
  • End date
    Jan 22, 2029
  • participants needed
    1000
  • sponsor
    Breast International Group
Updated on 22 January 2021
breast cancer
metastasis
primary tumor

Summary

This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer.

In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the "right therapy for each individual patient". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment metastatic lesion biopsy
Clinical Study IdentifierNCT02102165
SponsorBreast International Group
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Metastatic Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Women or men with metastatic or locally relapsed breast cancer manageable with systemic therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Written informed consent prior to enrollment into the program
Patient aged 18 years
Patient agrees to provide archived primary tumor tissue
Patient agrees to provide newly collected metastatic lesions tissue samples (archived material up to 6 months is allowed provided both Formalin Fixed Paraffin Embedded (FFPE) block and Frozen Tissue are available and were collected from the same lesion at the same time)
Patient agrees to provide blood samples

Exclusion Criteria

The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting
Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy
Patients with bone-only metastatic disease
Patients with brain-only metastatic disease, unless surgical excision is planned (in which case tissue will be collected for AURORA purpose)
Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI)
Platelet count<100 000/mm3, INR>1.5 (international normalized ratio; blood clotting time) , Albumin<30
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
Any anti-VEGF (vascular endothelial growth factor) or anti-VEGFR (vascular endothelial growth factor receptor) treatment administered less than 4 weeks before new biopsy procedure or no appropriate wash-out period for patients on anticoagulation therapy
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