Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Women's Cancer Study Group GmbH
With
Roche Pharma AG
Sanofi
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Arm A / Arm B
Age ≥ 18 years and ≤ 65 years
Female
Operable, locally advanced primary breast cancer (≥ cT2, N0 or N+, M0) histologically confirmed by core biopsy
Histologically confirmed unilateral, solitaire breast cancer
Patients who are candidates for neoadjuvant chemotherapy according to AGO guidelines (www.ago-online.de) with unifocal lesion
HER2 positive disease (IHC 3+ and/or FISH positive)or
HER2 negative disease (IHC 0/1+, IHC 2+ and/or FISH negative)
Baseline LVEF ≥ 55% (measured by MUGA or echocardiography) according to institution specific norm
Informed consent for clinical trial including analysis of predictive imaging tests and biomarkers
Clinically or by imaging (mammogram, MRI or US) assessed breast cancer ≥ 2 cm or inflammatory breast cancer with bi-dimensional measurable lesion independent of nodal status
Negative pregnancy test (urine or serum) within 7 days prior to registration if patient is premenopausal with intact reproductive organs and if patient is less than one year after menopause
ECOG Performance status 0-2
Adequate organ function for cytotoxic chemotherapy
Adequate renal function including Serum creatinine ≤ ULN, Measured or calculated creatinine clearance \> 60 ml/min
Urine dipstick for proteinuria \< 2+. In case of ≥ 2+ proteinuria on dipstick urinalysis, a 24-hour urine collection must be performed and protein per 24 hours must be ≤ 1.0 g
* Patients with dyspnoea at rest due to malignant or other disease or who require supportive oxygen therapy
* Active serious uncontrolled infections
* Poorly controlled diabetes
* History of hypertensive crisis or hypertensive encephalopathy
* History of TIA or CVA
* History of any arterial thrombotic event within 12 months before randomization
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
Clareo Health | Imaging for Response Assessment of Neoadjuvant Chemotherapy in Primary Breast Cancer (GALADON)
