NCT01520103

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 cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

January 25, 2012

Last Update Submit

August 8, 2017

Conditions

Her2-negative Metastatic Breast CancerHer2-negative Locally Advanced Breast Cancer

Keywords

Metastatic breast cancerlocally advanced breast cancerHer2/new negativeHER2 negative

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    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 Outcomes (4)

  • Safety and tolerability

    Assessment over 36 months

  • Rate of Progression Free Survival after 6 months (6 months PFSR)

    Assessment over 36 months

  • Overall survival (OS)

    36 months

  • Response rate (CR, PR)

    36 months

Study Arms (2)

Vinorelbin and Everolimus

EXPERIMENTAL
Drug: Vinorebine, Everolimus

standard therapy

OTHER

Vinorelbin

Drug: Vinorelbine

Interventions

Vinorebine, EverolimusDRUG

Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress

Vinorelbin and Everolimus
VinorelbineDRUG

Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress

standard therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hämatologisch-onkologische Gemeinschaftspraxis, Münster

Münster, 48149, Germany

Location

Related Publications (1)

  • Decker T, Marschner N, Muendlein A, Welt A, Hagen V, Rauh J, Schroder H, Jaehnig P, Potthoff K, Lerchenmuller C. VicTORia: a randomised phase II study to compare vinorelbine in combination with the mTOR inhibitor everolimus versus vinorelbine monotherapy for second-line chemotherapy in advanced HER2-negative breast cancer. Breast Cancer Res Treat. 2019 Aug;176(3):637-647. doi: 10.1007/s10549-019-05280-2. Epub 2019 May 21.

    PMID: 31115844DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EverolimusVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Christian Lerchenmüller, Dr.

    Hämatologisch-onkologische Gemeinschaftspraxis, Münster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

DE(1)