Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ludwig-Maximilians - University of Munich
With
AstraZeneca
Chugai Pharma USA
Eli Lilly and Company
Novartis
Sanofi
Janssen Diagnostics, LLC
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Primary epithelial invasive carcinoma of the breast pT1-4, pM0
Histopathological proof of axillary lymph node metastases (pN1-3) or high risk pN0/NX, defined as: 'pT ≥ 2 or histopathological grade 3 or age ≤ 35 or negative hormone receptor status'
Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
Females ≥ 18 years of age
Performance Status ≤ 2 on Eastern Cooperative Oncology Group (ECOG) Scale
Adequate bone marrow reserve: leucocytes ≥ 3.0 x 10\^9/l and platelets ≥ 100 x 10\^9/l
Bilirubin within one fold of the reference laboratory's normal range, aspartate aminotransferase (ASAT) (serum glutamate oxalacetate transaminase, SGOT), alanine aminotransferase (ALAT) (serum glutamate pyruvate transaminase, SGPT) and alkaline phosphatase (AP) within 1,5 fold of the reference laboratory's normal range for patients
Intention of regular follow-up visits for the duration of the study
Ability to understand the nature of the study and to give written informed consent
You may not be if
Inflammatory breast cancer
Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study
History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism)
Prior treatment with bisphosphonates within the last 6 months
Severe renal insufficiency as evidenced by creatinine clearance \< 30 ml/min as calculated using the Cockcroft-Gault formula
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Cardiomyopathy with impaired ventricular function (New York Heart Association Functional Classification Class (NYHA) \> II), cardiac arrythmias influencing left ventricular ejection fraction (LVEF) and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
Any known hypersensitivity against docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine or any other medication included in the study protocol
Use of any investigational agent within 3 weeks prior to inclusion
Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
