Know Cancer

forgot password

Randomized Phase II Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Her2-negative Metastatic Breast Cancer, Her2-negative Locally Advanced Breast Cancer

Thank you

Trial Information

Randomized Phase II Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer

Inclusion Criteria:

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 Criteria:

1. Previous treatment with Vinorelbine or an inhibitor of mTOR

2. Treatment with other study medication within 28 days before start of treatment

3. Patients who have received prior radiotherapy to ≥ 25% of the bone marrow

4. Other tumours in the previous 5 years with exception of an adequately treated basal
cell carcinoma of the skin or a preinvasive cervix carcinoma

5. 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

6. 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

7. 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

8. Known HIV infection or chronic hepatitis B or C or history of hepatitis B / C

9. Active clinically relevant infection (> grade 2 NCI-CTC Version 4.03)

10. Clinical or radiological detection of CNS metastases

11. 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

12. Active bleeding diathesis or an oral anti-vitamin K medication (except low-dose
warfarin and aspirin or equivalent, as long as the INR ≤ 2)

13. Kidney function disorder requiring dialysis

14. Seriously impaired liver function (Child-Pugh, class C)

15. Known hypersensitivity reaction to Vinorelbine or Everolimus

16. Pregnant or breast-feeding subjects

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse or death.

Outcome Time Frame:

Assessment over 36 months, minimum 12 month

Safety Issue:


Principal Investigator

Christian Lerchenmüller, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hämatologisch-onkologische Gemeinschaftspraxis, Münster


Germany: Ethics Commission

Study ID:




Start Date:

January 2012

Completion Date:

June 2015

Related Keywords:

  • Her2-negative Metastatic Breast Cancer
  • Her2-negative Locally Advanced Breast Cancer
  • Metastatic breast cancer
  • locally advanced breast cancer
  • Her2/new negative
  • HER2 negative
  • Breast Neoplasms