HER2/neu-negative, ER/PR positive inoperable or metastatic adenocarcinoma of the breast MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: P
Conditions
Interventions
Product Name: Exemestane
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Exemestane
CAS Number: 107868-30-4
Other descriptive name: EXEMESTANE
Concentration unit: mg milligram(s)
Concentr
Sponsors
iOMEDICO AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult women (= 18 years of age) 2. Postmenopausal status The investigator must confirm postmenopausal status. Postmenopausal status is defined either by: • Age = 55 years and one year or more of amenorrhea • Age =65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: 1. Prior palliative cytotoxic chemotherapies 2. Prior exposure to mTOR-Inhibitors (prior treatment with exemestane is allowed) 3. Concomitant antihormonal therapies, other than study medication 4. Symptomatic visceral metastases (as deemed by the investigator) 5. Uncontrolled CNS metastases 6. Unstable skeletal metastases 7. Medically uncontrolled cardiovascular diseases (e.g. uncontrolled hypertension) 8. Medically uncontrolled diabetes mellitus 9. Severe hepatic impairment (Child-Pugh C) 10. Inadequate organ function as specified below: • Hemoglobin < 9.0 g/dl • Absolute neutrophil count (ANC) <1,5 x109/L • Platelets <100 x109/L • Creatinine clearance < 30ml/min [Cockroft and Gault] 11. Known HIV infection or chronic hepatitis B or C or history of hepatitis B or C 12. Known dihydropyrimidin dehydrogenase (DPD) deficiency 13. Any other contraindications to the study drugs used or their excipients according to current SmPCs 14. Concomitant use of immunosuppressive agents or chronic use of systemic corticosteroids 15. Use of any other concomitant medication known to interfere with the study drugs 16. Use of concomitant medication known to interfere with the study results (e.g. hormonal therapy) during the whole study duration 17. Premenopausal patients 18. Pregnant or breast feeding patients 19. Participation in additional parallel interventional drug or device studies within four weeks before start of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To compare patients’ preferences of the two treatment combinations everolimus plus exemestane or capecitabine in combination with bevacizumab after failure of standard antihormonal therapy in patients with advanced (inoperable or metastatic) Her2/neu-negative hormone receptor positive breast cancer. ;Timepoint(s) of evaluation of this end point: The initially scheduled interim analysis will be omitted. Study data will be analyzed in the final analysis as planned based on the current number of randomized patients. The final analysis will take place once all patients have terminated trial therapy. This is planned for Q3 2017. ;Main Objective: The objective of this trial is to compare patients’ preferences of the two treatment combinations everolimus plus exemestane or capecitabine in combination with bevacizumab after failure of standard antihormonal therapy in patients with advanced (inoperable or metastatic) Her2/neu-negative hormone receptor positive breast cancer;Secondary Objective: • to evaluate reasons for preference as assessed by the patient preference questionnaire • to compare patient reported treatment satisfaction as assessed by the treatment satisfaction questionnaire in first- and second-line treatment • to investigate differences in quality of life by the EORTC QLQ-C30 and EORTC QLQ-FA13 questionnaire • to assess progression free survival rates after 12 weeks of therapy in first- (PFS rate 1) and second-line (PFS rate 2) • to assess clinical benefit by determining objective response rates and disease control rates based on tumor assessment as per RECIST 1.1 • to evaluate safety and tolerability throughout the study, including clinical laboratory, AEs and withdrawal of treatment due to AE • to determine physicians’ treatment preference as assessed by the physician preference questionnaire • to explore progression free survival and overall survival total and per line • to explore relationship between QoL scores and patient preferenc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • to evaluate reasons for preference as assessed by the patient preference questionnaire • to compare patient reported treatment satisfaction as assessed by the treatment satisfaction questionnaire in first- and second-line treatment • to investigate differences in quality of life by the EORTC QLQ-C30 and EORTC QLQ-FA13 questionnaire • to assess progression free survival rates after 12 weeks of therapy in first- (PFS rate 1) and second-line (PFS rate 2) • to assess clinical benefit by determining objective response rates and disease control rates based on tumor assessment as per RECIST 1.1 • to evaluate safety and tolerability throughout the study, including clinical laboratory, AEs and withdrawal of treatment due to AE • to determine physicians’ treatment preference as assessed by the physician preference questionnaire • to explore progression free survival and overall survival total and per line Exploratory objectives are: • to explore relationship between QoL scores and patient preference;Timepoint(s) of evaluation of this end point: The initially scheduled interim analysis will be omitted. Study data will be analyzed in the final analysis as planned based on the current number of randomized patients. The final analysis will take place once all patients have terminated trial therapy. This is planned for Q3 2017. | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
iOMEDICO AG
Outcome results
None listed