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New treatment option for Metastatic Breast Cancer
Official title AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
ClinicalTrials.gov ID: NCT02102165
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse \> 10...
- Written informed consent prior to registration into the program.
You likely can't join if
- 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.
- Presence of severe hematopoietic, renal, and/or hepatic dysfunction, including but not restricted to albumin \< 3 g/dl.
- Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.
- Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately...
See the full eligibility criteria
- 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...
- 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.
- Written informed consent prior to registration into the program.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Availability of primary tumor tissue for research purposes.
- Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.
- 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...
- In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.
- Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.
- 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...
- 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...
- Availability of a whole blood, serum and plasma samples collected at the time of screening.
- Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.
- 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.
- Presence of severe hematopoietic, renal, and/or hepatic dysfunction, including but not restricted to albumin \< 3 g/dl.
- Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Charleroi, Belgium
- Leuven, Belgium
- Liège, Belgium
- Namur, Belgium
- Essen, Germany
- München, Germany
- Reykjavik, Iceland
- Biella, Italy
- Bolzano, Italy
- Carpi, Italy
- Genova, Italy
- Legnago, Italy
- Milan, Italy
- Parma, Italy
- Pavia, Italy
- Reggio Emilia, Italy
- Luxembourg, Luxembourg
- Lisbon, Portugal
- A Coruña, Spain
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Charleroi, Belgium; Leuven, Belgium; Liège, Belgium; Namur, Belgium; Essen, Germany and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.