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

August 8, 2017 updated by: AIO-Studien-gGmbH

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

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 cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48149
        • Hämatologisch-onkologische Gemeinschaftspraxis, Münster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vinorelbin and Everolimus
Drug: Vinorebine, Everolimus
Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress
Other: standard therapy
Vinorelbin
Drug: Vinorelbine
Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Assessment over 36 months, minimum 12 month
Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse or death.
Assessment over 36 months, minimum 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Assessment over 36 months

Capture all adverse events, serious adverse events, all side effects of the study medication, serious side effects, adverse events that lead to temporary or complete discontinuation of the study treatment and the Rates and causes of death.

A safety interims analysis is planned, as soon as 60 subjects have finished at least two treatment cycles.
Assessment over 36 months
Rate of Progression Free Survival after 6 months (6 months PFSR)
Time Frame: Assessment over 36 months
descriptive Evaluation, for the monotherapy (arm 2) a median PFS of 4 months is assumed. It is expected that the combination therapy will prolong the median PFS to 6.5 months.
Assessment over 36 months
Overall survival (OS)
Time Frame: 36 months
The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation.
36 months
Response rate (CR, PR)
Time Frame: 36 months
The tumour status of patients will be evaluated nine weekly during the treatment until detection of progression.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIO-Studien-gGmbH

Collaborators

Novartis Pharmaceuticals
iOMEDICO AG

Investigators

  • Principal Investigator: Christian Lerchenmüller, Dr., Hämatologisch-onkologische Gemeinschaftspraxis, Münster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIO-MAM-0110
  • 2011-001024-38 (EudraCT Number)
  • CRAD001JDE38T (Other Identifier: Novartis Pharma GmbH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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