Status:
COMPLETED
Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
Lead Sponsor:
iOMEDICO AG
Collaborating Sponsors:
Arbeitsgemeinschaft fur Internistische Onkologie
Novartis Pharmaceuticals
Conditions:
Breast Cancer Recurrent
HER2/Neu-negative Carcinoma of Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This is a clinical trial with a crossover design to determine patients' preference for capecitabine in combination with bevacizumab or everolimus in combination with exemestane for advanced breast can...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained prior to any study specific procedure.
- Adult women (≥ 18 years of age)
- . 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 \< 55 years and one year or more of amenorrhea and postmenopausal levels of follicle stimulating hormone (FSH) and Luteinizing hormone (LH) per local institutional standards
- Prior hysterectomy and has postmenopausal levels of FSH and LH per local institutional standards
- Surgical menopause with bilateral oophorectomy
- For women with therapy-induced amenorrhea, oophorectomy or serial measurements of FSH and / or estradiol are needed to ensure postmenopausal status.
- Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.
- Pathologically confirmed HER2/neu-negative, ER/PR positive inoperable or metastatic adenocarcinoma of the breast
- Indication for systemic palliative targeted therapy / first line chemotherapy after failure of at least one non-steroidal aromatase inhibitor therapy at any time during the disease course (no restriction regarding the number of previous endocrine lines)
- No indication for other chemotherapeutic treatment including Taxanes or Anthracyclines
- Measurable or non-measurable disease as per RECIST 1.1
- Adequate bone marrow, liver and renal function (according to current SmPCs of both treatment regimens)
- ECOG performance status 0-2
- Fluent German (spoken and written) language
Exclusion
- Prior palliative cytotoxic chemotherapies
- Prior exposure to mTOR-Inhibitors (prior treatment with exemestane is allowed)
- Concomitant antihormonal therapies, other than study medication
- Symptomatic visceral metastases (as deemed by the investigator)
- Uncontrolled CNS metastases
- Unstable skeletal metastases
- Medically uncontrolled cardiovascular diseases (e.g. uncontrolled hypertension)
- Medically uncontrolled diabetes mellitus
- Severe hepatic impairment (Child-Pugh C)
- 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 \[Cockcroft and Gault\]
- Known HIV infection or chronic hepatitis B or C or history of hepatitis B or C
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Any other contraindications to the study drugs used or their excipients according to current SmPCs
- Concomitant use of immunosuppressive agents or chronic use of systemic corticosteroids
- Use of any other concomitant medication known to interfere with the study drugs
- Use of concomitant medication known to interfere with the study results (e.g. hormonal therapy) during the whole study duration
- Premenopausal patients
- Pregnant or breast feeding patients
- Participation in additional parallel interventional drug or device studies within four weeks before start of study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2017
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT02248571
Start Date
August 1 2014
End Date
September 30 2017
Last Update
November 13 2017
Active Locations (1)
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1
iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79108