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CancerPhase 2VITALNCT01013740

Lapatinib in Combination With Vinorelbine

A Phase 2 study testing Vinorelbine, Lapatinib and Capecitabine in people with Cancer, run by Novartis Pharmaceuticals at 53 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer
What is being tested?
Vinorelbine, Lapatinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
53 sitesin 10 countries
Study dates
25 Nov 2009to 1 Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed informed consent prior to registration.
  • Considered by the investigator to have a life expectancy of ≥12 weeks.
  • Subjects must be female and have histologically - confirmed invasive breast cancer with Stage IV disease at primary diagnosis or at relapse after curative - intent surgery.
  • Documented overexpression of ErbB2
  • Subjects should have progressive disease following prior therapy which may include anthracyclines, taxanes, and trastuzumab.
  • Females aged ≥18 years
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
  • Subjects must have adequate organ and marrow function
  • Subjects must have a cardiac ejection fraction of at least 50% and within the institutional range of normal.
  • Radiotherapy prior to initiation of study medication is allowed to a limited area ( e . g . , palliative therapy ) , if it is not the sole site of disease.
  • Subjects with stable central nervous system (CNS) metastases are permitted.
  • Subject must be free of gastrointestinal diseases or any other conditions that impede swallowing, retaining, and absorption of oral medications.
  • Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of study medication. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted.

Who cannot join

  • Subjects taking prohibited medications are not eligible for the study.
  • Therapy with lapatinib, vinorelbine, or capecitabine prior to randomization into this study.
  • Prior therapy with more than one chemotherapeutic regimen for metastatic breast cancer.
  • Concurrent anticancer or concomitant radiotherapy treatment.
  • History of uncontrolled or symptomatic angina; history of arrhythmias requiring medications ; clinically significant myocardial infarction < 6 months from study entry; uncontrolled or symptomatic congestive heart failure; ejection fraction below the institutional normal limit; or any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
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  • Use of an investigational drug within 30 days or 5 half - lives, whichever is longer, preceding the first dose of investigational treatment, or, concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients that in the opinion of the investigator or GSK Medical Monitor contraindicates their participation.
  • Known deficiency for the enzyme dihydropyrimidine dehydrogenase (DPD).
  • Known history of uncontrolled inter - current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements.
  • Concurrent disease or condition that would make the subject inappropriate for study participation , or any serious medical disorder that would interfere with the subject's safety.
  • Pregnant or lactating females at any time during the study (due to the potential teratogenic or abortifacient effects of lapatinib and breastfeeding).
  • Subjects with diseases affecting gastrointestinal function resulting in an inability to take oral medication , including ; malabsorption syndrome, disease significantly affecting gastrointestinal function , or resection of the stomach , small bowel , or colon. Subjects with inflammatory bowel disease or ulcerative colitis are also excluded.
  • Peripheral neuropathy of Grade 2 or greater.
  • Unresolved or unstable, serious toxicity from prior administration of another investigational drug and / or of prior cancer treatment.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Trial locations and contacts

53 sites in 10 countries.

53 sites in 10 countries

Germany11 sites

  • Novartis Investigative Site

    Bad Nauheim, Hesse, 61231

  • Novartis Investigative Site

    Berlin, State of Berlin, 12200

  • Novartis Investigative Site

    Chemnitz, Saxony, 09116

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    München, Bavaria, 80638

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Novartis Investigative Site

    Munich, Bavaria, 80337

  • Novartis Investigative Site

    Rheinfelden, Baden-Wurttemberg, 79618

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

Italy8 sites

  • Novartis Investigative Site

    Ancona, The Marches, 60020

  • Novartis Investigative Site

    Brescia, Lombardy, 25124

  • Novartis Investigative Site

    Brindisi, Apulia, 72100

  • Novartis Investigative Site

    Catania, Sicily, 95124

  • Novartis Investigative Site

    Catania, Sicily

  • Novartis Investigative Site

    Genoa, Liguria, 16132

  • Novartis Investigative Site

    Turin, Piedmont, 10126

  • Novartis Investigative Site

    Verona, Veneto, 37135

Other trials in Italy

Spain8 sites

  • Novartis Investigative Site

    Fuenlabrada (Madrid), 28942

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Marbella, 29600

  • Novartis Investigative Site

    Pamplona, 31008

  • Novartis Investigative Site

    Reus, 43201

  • Novartis Investigative Site

    Segovia, 40002

  • Novartis Investigative Site

    Vigo (Pontevedra), 36204

  • Novartis Investigative Site

    Zamora

Other trials in Spain

Poland7 sites

  • Novartis Investigative Site

    Gdansk, 80-219

  • Novartis Investigative Site

    Gliwice, 44-101

  • Novartis Investigative Site

    Konin, 62-500

  • Novartis Investigative Site

    Lodz, 93-509

  • Novartis Investigative Site

    Lublin, 20-090

  • Novartis Investigative Site

    Olsztyn, 10-513

  • Novartis Investigative Site

    Warsaw, 04-125

Other trials in Poland

Bulgaria4 sites

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

France4 sites

  • Novartis Investigative Site

    Bayonne, 64100

  • Novartis Investigative Site

    Marseille, 13009

  • Novartis Investigative Site

    Nîmes Cedex 9, 30029

  • Novartis Investigative Site

    Saint-Cloud, 92210

Other trials in France

Greece4 sites

  • Novartis Investigative Site

    Athens, 115 22

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Heraklion,Crete, 71110

  • Novartis Investigative Site

    Thessaloniki, 564 29

Other trials in Greece

Chile3 sites

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 750 1088

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 7650635

  • Novartis Investigative Site

    Viña Del Mar, ValparaÃ-so, 2520612

Other trials in Chile

Mexico2 sites

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64060

  • Novartis Investigative Site

    Oaxaca City, Oaxaca, 68000

Other trials in Mexico

Serbia2 sites

  • Novartis Investigative Site

    Belgrade

  • Novartis Investigative Site

    Kamenitz, 21204

Other trials in Serbia

About this study

Official title: A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer

This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.

Read the detailed description

Approximately 105 subjects will be enrolled in the study and randomized 2:1 to one of the following regimens Arm A (n=70): Lapatinib 1250 mg orally once daily continuously plus Vinorelbine 20mg/m2 intravenously (IV) on day 1 and 8, every third week, or Arm B (n=35): Lapatinib 1250 mg orally once daily (QD) continuously plus Capecitabine 2000 mg/m2/day orally in 2 doses 12 hours apart on days 1-14 every third week. Randomization will be stratified according to the following variables: 1) Prior receipt of therapy for metastatic breast cancer (Yes or No), and 2) Site of metastatic disease (Visceral/Soft tissue or Bone-only). Subjects will receive randomized study treatment until disease progression or discontinuation of study treatment due to unacceptable toxicity, withdrawal of consent, lost to follow up, or death. All subjects who discontinue study treatment without documented progression will continue to be followed for progression according to protocol-schedule until new anti-cancer therapy is initiated and/or progression or death is documented. Survival data will be collected for all subjects to ensure a minimum of 18 months survival data. This study will include a safety run-in phase for approximately the first 30 subjects (20 randomized to lapatinib and vinorelbine; 10 to lapatinib and capecitabine).

Conditions
Cancer
Being tested
Vinorelbine, Lapatinib, Capecitabine
Keywords
Neoplasms, Breast
Medical subject headings
Neoplasms, Breast Neoplasms

What participants receive

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

  • VinorelbineDrug

    Vinorelbine

  • LapatinibDrug

    Lapatinib

  • CapecitabineDrug

    Capecitabine

Study groups in NCT01013740
Study groupRoleWhat they receive
Lapatinib + VinorelbineExperimentalLapatinib + Vinorelbine
Receives: Drug: Vinorelbine; Drug: Lapatinib
Lapatinib + CapecitabineActive comparatorLapatinib + Capecitabine
Receives: Drug: Lapatinib; Drug: Capecitabine

What is being measured

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

  1. Progression Free Survival (PFS) in the Randomized Phase

    PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)

Secondary outcomes (8)

  1. Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase

    OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)

  2. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

    Measured: From the date of randomization until death (average of 55 study weeks)

  3. Duration of Response (DOR) in the Randomized Phase

    DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.

    Measured: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)

  4. Time to Response in the Randomized Phase

    Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.

    Measured: From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)

  5. Number of Participants With Clinical Benefit (CB) in the Randomized Phase

    CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)

  6. Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine

    AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.

    Measured: Days 1 and 8; 0 to 24 hours post-dose

  7. Maximum Concentration (Cmax) for Vinorelbine

    Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.

    Measured: Days 1 and 8; 0 to 24 hours post-dose

  8. Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)

Timeline

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

  1. First posted16 Nov 2009 (estimated)
  2. Study start25 Nov 2009
  3. Primary completion21 Aug 2012
  4. Study completion1 Mar 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
Crossover
Model description
After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01013740
Sponsor's protocol ID
CLAP016A2205 / 112620
Acronym
VITAL
Status last verified
Mar 2017
First submitted
29 Oct 2009
Last updated
31 May 2017
Data monitoring committee
No

Publications

  • Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

    PubMed 34037241

  • Janni W, Sarosiek T, Karaszewska B, Pikiel J, Staroslawska E, Potemski P, Salat C, Brain E, Caglevic C, Briggs K, Mahood K, DeSilvio M, Marini L, Papadimitriou C. Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer. Breast. 2015 Dec;24(6):769-73. doi: 10.1016/j.breast.2015.08.005. Epub 2015 Sep 16.

    PubMed 26384789

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, Lapatinib and Capecitabine in people with Cancer, run by Novartis Pharmaceuticals at 53 sites in 10 countries.

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 13 inclusion and 16 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Germany, Italy, Spain, Poland, Bulgaria and 5 more countries. 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?

Yes. Results are posted in the registry (first posted 18 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) in the Randomized Phase (time frame: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)). 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 NCT01013740, which also lists 2 linked publications.

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 31 May 2017.

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