Status:
COMPLETED
Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer
Lead Sponsor:
AIO-Studien-gGmbH
Collaborating Sponsors:
iOMEDICO AG
Novartis Pharmaceuticals
Conditions:
Her2-negative Metastatic Breast Cancer
Her2-negative Locally Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is Examination of the superiority of a combination of vinorelbine with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in advanced breast ...
Eligibility Criteria
Inclusion
- 1 .Dated and signed patient informed consent before start of any in the protocol specified procedures 2. Histologically or cytologically confirmed Her2/neu negative, metastatic or locally advanced breast cancer, including inoperable local relapse, with measurable or non-measurable lesions for which
- a palliative second line chemotherapy is indicated. Antihormone palliative pretreatments do not count as separate treatment lines
- treatment with anthracycline and/or taxanes has failed or is not suitable
- which cannot be adequately treated by operation or radiotherapy on its own 3. An exclusive anti-hormone therapy is not indicated for the patient 4. ECOG Performance Status of 0-2 5. Women \>= 18 years of age 6. Life expectancy of at least 12 weeks 7. Adequate bone marrow, liver and renal function (according to SmPC of Vinorelbine, Afinitor®) based on laboratory assessments raised within 7 days prior to start of study treatment:
- Haemoglobin \>= 9.0 g/dl
- Absolute neutrophil count (ANC) \>= 2/mm³
- Thrombocytes \>= 100/µl
- INR \>= 2
- Serum bilirubin =\< 1.5x upper limit of normal ( in patients with known Gilbert syndrome, total bilirubin =\< 3x upper limit of normal, with direct bilirubin =\< 1.5x upper limit of normal
- ALT and AST =\< 2.5x upper limit of normal (=\< 5x upper limit of normal in subjects with liver metastases)
- Serum cholesterol =\< 300 mg/dl or 7.75 mmol/l and triglycerides =\< 2.5x upper limit of normal (with lipid lowering drugs permitted)
- Serum creatinin =\< 2x upper limit of normal 8. Documentation of a negative pregnancy test in women of childbearing potential within 7 days prior to start of study. Sexual active pre-menopausal women are required to use adequate contraception throughout the duration of the study, except for oestrogen containing contraceptives
Exclusion
- Previous treatment with Vinorelbine or an inhibitor of mTOR
- Treatment with other study medication within 28 days before start of treatment
- Patients who have received prior radiotherapy to ≥ 25% of the bone marrow
- Other tumours in the previous 5 years with exception of an adequately treated basal cell carcinoma of the skin or a preinvasive cervix carcinoma
- Simultaneous use of known CYP3A4 inducers (e.g. Phenytoin, Rifampicin) or inhibitors of this enzyme (e.g. Itraconazole, Ketoconazole), therefore also use of mistletoe, St John's wort or grapefruit juice
- Patients to whom at least one of the conditions applies:
- Substance abuse
- medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- Legal incapacity or limited legal capacity
- Subjects who are unable to take oral medication
- Any condition that could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
- History of cardiac dysfunction including one of the following:
- Myocardial infarction by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
- History of documented congestive heart failure (NYHA ≥ 3)
- Documented cardiomyopathy
- Known HIV infection or chronic hepatitis B or C or history of hepatitis B / C
- Active clinically relevant infection (\> grade 2 NCI-CTC Version 4.03)
- Clinical or radiological detection of CNS metastases
- Patients receiving concomitant immunosuppressive agents or chronic use of corticosteroids at the time of study entry except in cases outlined below:
- topical applications (e.g. rash,) inhaled sprays, (e.g. obstructive airway diseases) eye drops or local injections (e.g. intraarticular) are allowed
- Active bleeding diathesis or an oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR ≤ 2)
- Kidney function disorder requiring dialysis
- Seriously impaired liver function (Child-Pugh, class C)
- Known hypersensitivity reaction to Vinorelbine or Everolimus
- Pregnant or breast-feeding subjects
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2016
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT01520103
Start Date
January 1 2012
End Date
October 31 2016
Last Update
August 9 2017
Active Locations (1)
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1
Hämatologisch-onkologische Gemeinschaftspraxis, Münster
Münster, Germany, 48149