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AzTrials

Her2-negative Metastatic Breast CancerPhase 2VicTORiaNCT01520103

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

A Phase 2 study testing Vinorebine, Everolimus and Vinorelbine in people with Her2-negative Metastatic Breast Cancer and Her2-negative Locally Advanced Breast Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Vinorebine, Everolimus and Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteGermany
Study dates
Jan 2012to 31 Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Hämatologisch-onkologische Gemeinschaftspraxis, Münster

    Münster, 48149

Other trials in Germany

About this study

Official title: 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.

Being tested
Vinorebine, Everolimus, Vinorelbine
Keywords
Metastatic breast cancer, locally advanced breast cancer, Her2/new negative, HER2 negative
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vinorebine, EverolimusDrug

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

  • VinorelbineDrug

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

Study groups in NCT01520103
Study groupRoleWhat they receive
Vinorelbin and EverolimusExperimentalNot described
Receives: Drug: Vinorebine, Everolimus
standard therapyOtherVinorelbin
Receives: Drug: Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessment over 36 months, minimum 12 month

Secondary outcomes (4)

  1. Safety and tolerability

    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.

    Measured: Assessment over 36 months

  2. Rate of Progression Free Survival after 6 months (6 months PFSR)

    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.

    Measured: Assessment over 36 months

  3. Overall survival (OS)

    The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation.

    Measured: 36 months

  4. Response rate (CR, PR)

    The tumour status of patients will be evaluated nine weekly during the treatment until detection of progression.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completion31 Oct 2016
  4. Study completion31 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01520103
Sponsor's protocol ID
AIO-MAM-0110
Other IDs
2011-001024-38, CRAD001JDE38T
Acronym
VicTORia
Status last verified
Aug 2017
First submitted
25 Jan 2012
Last updated
9 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31115844

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorebine, Everolimus and Vinorelbine in people with Her2-negative Metastatic Breast Cancer and Her2-negative Locally Advanced Breast Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Assessment over 36 months, minimum 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01520103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.

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