ABOUT THIS STUDY
1. Post- or pre/peri-menopausal female patients, age ≥18 years
2. Patients with metastatic or locally advanced (non-operable) breast cancer disease
3. Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination therapy OR Patients having already received endocrine therapy who are appropriate candidates for fulvestrant+ palbociclib combination therapy
4. Patient has not received treatment for locally advanced or metastatic disease OR Patient has received one prior line of chemotherapy and/or a maximum of two endocrine therapy lines for locally advanced or metastatic disease
5. Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..
6. The tumor must be hormone-receptor positive
7. The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by in situ hybridization..
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9. Adequate organ and marrow function before palbociclib treatment starts on C1D.
10. In case of patients of child bearing potential: negative pregnancy test (urine or serum) at baseline. Patients must agree to use highly effective non-hormonal contraception
11. Resolution of all acute toxic effects of prior therapy, including radiotherapy grade <1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
12. Signed Written Informed Consent
13. Willingness and capability to use CANKADO
14. Availability of hardware: Computer and/or tablet and/or smartphone with internet access
1. Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its
2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists
3. Prior treatment with any inhibitor of cyclin dependent kinase (CDK).
4. Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at
risk of life threatening complications in the short term
5. Known active uncontrolled or symptomatic central nervous system metastases
6. Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome
P450 3A4 (CYP3A4)
7. High cardiovascular risk, including, but not limited to recent myocardial infarction,
severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months of
8. Diagnosis of any second malignancy within the last 5 years prior to enrollment, except
for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
of the cervix
9. Participation in other clinical trials involving investigational drug(s) (Phases 1-4)
within 2 weeks before the current study begins and/or during study participation
10. Lactating women
11. Life expectancy < 3 months
12. Known infection with HIV, hepatitis B virus, or hepatitis C virus
13. Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that
might interfere with the planned treatment and with the patient's adherence to the
14. Legal incapacity or limited legal capacity.
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