Status and phase
Conditions
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About
The GALADON trial is a diagnostic and interventional study in which different molecular imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods (mammography, ultrasound) to see if there can detect an early response to a combined neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to the Her2-protein is much more powerful than with chemotherapy alone because it is normalizing the blood supply and improves tumor delivery of conventional chemotherapy like docetaxel. The HER2 protein is only available in about 30 % of breast cancer types. bevacizumab is another humanized monoclonal antibody like trastuzumab but is effective not only in patients with an positive HER2 status and in combination with trastuzumab it may emphasize the effect in reduction of tumor growth. Bevacizumab is approved in advanced disease, but no major neoadjuvant data available so far for primary breast cancer. As the therapy with monoclonal antibody regimes are expensive and may cause severe side effects predictive factors to select patients who will benefit from such highly specific drugs before therapy start would be medically and economically highly valuable. In this study the efficacy of combined neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in Arm A and bevacizumab and docetaxel in Arm B should be evaluated and the predictive impact of different imaging methods for tumor response should be shown.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Arm A / Arm B
Exclusion criteria
Arm A / Arm B
Evidence of distant metastases by clinical or imaging diagnosis
Multifocal primary tumour, defined as histologically confirmed tumour-manifestations within different quadrants; distance ≥ 4 cm
Pre-existing motor or sensory neuropathy of a severity ≥ grade 2 NCI criteria
Previous breast cancer
Prior malignancy with a disease-free survival of < 5 years
Prior malignancy which has not been curatively treated
Inflammatory breast cancer without bi-dimensional measurable lesion
Prior systemic therapy for cancer
Previous therapy with trastuzumab or other anti-HER2 agent (for HER2+ tumors)
Previous therapy with bevacizumab or other anti-VEGF agent
Patients with immunosuppressive therapy
Pregnant or lactating women
Women of childbearing potential not using highly effective birth control.
Patients with known hypersensitivity reactions to the compounds or incorporated substances of trastuzumab or its constituents (for HER2+ tumors).
Patients with known hypersensitivity reactions to the compounds or incorporated substances of bevacizumab or its constituents.
Invasive malignancy which could affect compliance with the protocol or interpretation of results.
Other serious illness or medical condition including:
Inadequate bone marrow, hepatic and renal functions as evidenced by the following:
Neutrophil count of < 1500, platelet count of < 100,000/µL
Haemoglobin < 10 g/dL
Serum total bilirubin > ULN (except for patients with clearly documented Gilbert's syndrome)
ALT or AST > 1.5 x ULN
Alkaline phosphatase > 2.5 x ULN, serum creatinine > ULN
Concurrent treatment with any other anti-cancer therapy
No informed consent for analysis of predictive imaging tests and biomarkers
Contraindications against MRI: Cardiac pacemakers, other forms of medical or biostimulation implants, ferromagnetic foreign bodies or metallic implants (e.g. surgical protheses, aneurysm clips), implanted insulin pumps, valvular implants, allergy to contrast agent, renal insufficiency, claustrophobia
Active peptic ulcer, incomplete wound healing or unhealed bone fracture
Previous thromboembolic events, known hemorrhagic diathesis, coagulopathy with increased bleeding risk, or treatment with anticoagulants. Current or recent (within 10 days of first dose of bevacizumab) use of acetalic acid (> 325 mg/day) or clopidogrel (> 75 mg/day)
Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel, ulcerative colitis; abdominal fistula, intra-abdominal abscess within 6 months of enrolment or gastrointestinal perforation
Major surgery within the last 28 days or anticipation of the need for major surgery during study treatment with bevacizumab. No minor surgeries including insertion of an indwelling catheter within 24h prior to registration.
Concurrent treatment with other experimental drugs; participation in another clinical trial with any investigational drug within 30 days prior to study entry
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
Patients with a history of hypersensitivity reaction to docetaxel or to drugs formulated with polysorbate 80
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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