- AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer. — Recruiting • Non-phase study • Oncology • NCT02102165.
- Being tested: AURORA is evaluating molecular aberrations in metastatic breast cancer through comprehensive genomic profiling to identify genetic and molecular drivers of disease progression in treatment-Non-phase studyïve or minimally pretreated patients.
- Patient eligibility overview: The trial recruits adults aged ≥18 years (both male and female) across European hospitals with metastatic breast cancer who have received no more than one prior treatment line, ensuring a relatively homogeneous population with limited prior therapeutic exposure.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : 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 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.
- 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.