Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Netherlands Cancer Institute
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
≥18 years of age
Histological proven breast cancer or local recurrence of breast cancer which is inoperable or/and metastatic, including inflammatory breast cancer
No participation in trial with neoadjuvant systemic treatment, except for previous contralateral breast cancer
Tumor in breast accessible for biopsy
WHO performance 0-2
Life expectancy of at least 6 months
Adequate hematological, renal and hepatic functions
Hemoglobin 6.2 mmol/l
Leucocytes 3.0 x 10E9/l
* Absolute neutrophil count 1.5x10E9/l
* Platelet count 100 x 10E9/l
* Total bilirubin ≤ 1.5 x ULN
* ASAT/ALAT ≤ 2.5 x ULN; or in the presence of liver metastases ≤ 5 x ULN
* Creatinine clearance 50 ml/min; measured or calculated
Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 21 days of study treatment. Non-childbearing potential or postmenopausal is defined as:
* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
* LH and FSH levels in post menopausal range for women under 50 years of age
* Radiation-induced oophorectomy with last menses \> 1 year ago
* Chemotherapy-induced menopause with \> 1 year interval since last menses
* Surgical sterilisation (bilateral oophorectomy or hysterectomy)
Patients of reproductive potential must agree to practice two effective medically approved contraceptive method during the trial and 3 months afterwards
Signed written informed consent
You may not be if
Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within 3 weeks prior to start of therapy (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin ornitrosourea). Patient may continue the use of tamoxifen, aromatase inhibitor and LHRH agonists for cancer; bisphosphonates for bone disease and corticosteroids. The use of denosumab for bone disease is not allowed.
Major surgery within two weeks of starting study treatment.
Participation in other trial with investigational drug or treatment modality
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required.
Prior ipsilateral radiotherapy to the chest or breast.
Blood transfusion in the four weeks prior to study entry
Persistent toxicities (CTC ≥ grade 2) with the exception of alopecia, caused by previous cancer therapy
QT-interval \> 470 msec
Significant cardiovascular disease as defined by
* History of congestive heart failure defined as NYHA class III
* History of unstable angina pectoris or myocardial infarction up to 3 months prior to trial entry;
* Presence of severe valvular heart disease
* Presence of a ventricular arrhythmia requiring treatment;
