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

 1. Women or men with metastatic or locally relapsed breast cancer manageable with
 systemic therapy

 2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

 3. Written informed consent prior to enrollment into the program.

 4. Patient aged ≥ 18 years

 5. Patient agrees to provide archived primary tumor tissue

 6. 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)

 7. Patient agrees to provide blood samples

 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. Patients with bone-only metastatic disease

 4. Patients with brain-only metastatic disease, unless surgical excision is planned (in
 which case tissue will be collected for AURORA purpose)

 5. Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according
 to the local PI)

 6. Platelet count<100 000/mm3, INR>1.5 (international normalized ratio; blood clotting
 time) , Albumin<30

 7. 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

 8. 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