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AzTrials

Metastases, BrainPhase 3NCT00820222

Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

A Phase 3 study testing capecitabine, lapatinib and trastuzumab in people with Metastases, Brain, run by Novartis Pharmaceuticals at 164 sites in 14 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 open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastases, Brain
What is being tested?
capecitabine, lapatinib and trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
164 sitesin 14 countries
Study dates
14 Apr 2009to 22 Mar 2018
Phase
Phase 3
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

  • Females at least 18 years old;
  • ECOG Performance Status 0-2;
  • Histologically or cytologically confirmed HER2-positive invasive breast cancer, with Stage IV disease;
  • Prior treatment with taxanes or anthracyclines is required;
  • Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and radiation therapy is permitted;
  • Baseline LVEF ≥ 50% and not lower than the institutional lower limit of normal;
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  • Concurrent treatment with bisphosphonates is permitted, however treatment must be initiated prior to the first dose of study therapy;
  • Able to swallow and retain oral medications;
  • Women with potential to have children must be willing to practice acceptable methods of birth control during the study;
  • Normal organ and marrow function.

Who cannot join

  • History and/or current evidence of CNS metastases. Baseline MRI scan by Independent Reviewer to confirm no brain mets;
  • Concurrent treatment with an investigational agent or participation in another treatment clinical trial;
  • Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab (including but not limited to trastuzumab-DM1 and neratinib) and capecitabine;
  • Known DPD deficiency;
  • Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for treatment of cancer;
  • History of allergic reactions attributed to compounds chemically related to lapatinib (quinazolines), capecitabine, fluorouracil or any excipients;
Show all 17Show fewer
  • Concomitant use of CYP3A4 inhibitors or inducers;
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel;
  • History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast and other known contraindication to MRI;
  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the patient's safety or compliance to study procedures;
  • have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease);
  • Any on-going toxicity from prior anti cancer therapy except alopecia;
  • Active cardiac disease;
  • Uncontrolled infection;
  • History of other malignancy, unless curatively treated with no evidence of disease for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are eligible;
  • Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of protocol treatment;
  • Pregnant or lactating females.

Trial locations and contacts

164 sites in 14 countries.

164 sites in 14 countries

Germany30 sites

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Bottrop, North Rhine-Westphalia, 46236

  • Novartis Investigative Site

    Brandenburg, 14770

  • Novartis Investigative Site

    Bremen, 28209

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50935

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 51067

  • Novartis Investigative Site

    Duisburg, North Rhine-Westphalia, 47166

  • Novartis Investigative Site

    Eggenfelden, Bavaria, 84307

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60389

  • Novartis Investigative Site

    Fürth, Bavaria, 90766

  • Novartis Investigative Site

    Goch, North Rhine-Westphalia, 47574

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Herne, North Rhine-Westphalia, 44623

  • Novartis Investigative Site

    Landshut, Bavaria, 84028

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23562

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Munich, Bavaria, 81925

  • Novartis Investigative Site

    Nuremberg, Bavaria, 90449

  • Novartis Investigative Site

    Potsdam, Brandenburg, 14467

  • Novartis Investigative Site

    Ravensburg, Baden-Wurttemberg, 88212

  • Novartis Investigative Site

    Rosenheim, Bavaria, 83022

  • Novartis Investigative Site

    Speyer, Rhineland-Palatinate, 67346

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65199

  • Novartis Investigative Site

    Witten, North Rhine-Westphalia, 58452

  • Novartis Investigative Site

    Würselen, North Rhine-Westphalia, 52146

  • Novartis Investigative Site

    Würzburg, Bavaria, 97070

Other trials in Germany

Spain18 sites

  • Novartis Investigative Site

    A Coruña, 15009

  • Novartis Investigative Site

    Barcelona, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Cáceres, 10003

  • Novartis Investigative Site

    Hospitalet de Llobregat (Barcelona), 08907

  • Novartis Investigative Site

    Jerez (Cadiz), 11047

  • Novartis Investigative Site

    Lleida, 25198

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Palma de Mallorca, 07010

  • Novartis Investigative Site

    Palma de Mallorca, 07198

  • Novartis Investigative Site

    Santiago de Compostela, 15706

  • Novartis Investigative Site

    Seville, 41013

  • Novartis Investigative Site

    Seville, 41014

  • Novartis Investigative Site

    Torrevieja (Alicante), 03186

  • Novartis Investigative Site

    Valencia, 46010

Other trials in Spain

United Kingdom18 sites

  • Novartis Investigative Site

    Aberdeen, AB25 2ZN

  • Novartis Investigative Site

    Birmingham, West Midlands, B18 7QH

  • Novartis Investigative Site

    Burton-on-Trent, DE13 0RB

  • Novartis Investigative Site

    Cottingham, Hull, HU16 5JQ

  • Novartis Investigative Site

    Edinburgh, Midlothian, EH4 2XU

  • Novartis Investigative Site

    Huddersfield, HD3 3EA

  • Novartis Investigative Site

    Ipswich, IP4 5PD

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    Maidstone, ME16 9QQ

  • Novartis Investigative Site

    Nottingham, NG5 1PB

  • Novartis Investigative Site

    Peterborough, PE3 9GZ

  • Novartis Investigative Site

    Sheffield, S10 2SJ

  • Novartis Investigative Site

    Shrewsbury, SY3 8XQ

  • Novartis Investigative Site

    Southampton, SO16 6YD

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

  • Novartis Investigative Site

    Worthing, BN11 2DH

Other trials in United Kingdom

United States17 sites

  • Novartis Investigative Site

    Anaheim, California, 92801

  • Novartis Investigative Site

    Boca Raton, Florida, 33486

  • Novartis Investigative Site

    Coral Springs, Florida, 33065

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    Goodyear, Arizona, 85338

  • Novartis Investigative Site

    Great Falls, Montana, 59405

  • Novartis Investigative Site

    Greenbrae, California, 94904-2007

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Jonesboro, Arkansas, 72401

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Sacramento, California, 95816

  • Novartis Investigative Site

    Santa Barbara, California, 93105

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    Tucson, Arizona, 85715

  • Novartis Investigative Site

    Voorhees Township, New Jersey, 08043

  • Novartis Investigative Site

    Warrenville, Illinois, 60555

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

Russia17 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Chelyabinsk, 454087

  • Novartis Investigative Site

    Kazan', 420029

  • Novartis Investigative Site

    Kirov, 610021

  • Novartis Investigative Site

    Moscow, 115 478

  • Novartis Investigative Site

    Moscow, 117997

  • Novartis Investigative Site

    Moscow Region, 143 423

  • Novartis Investigative Site

    Nizhny Novgorod, 603081

  • Novartis Investigative Site

    Obninsk, 249036

  • Novartis Investigative Site

    Petrozavodsk, 185035

  • Novartis Investigative Site

    Ryazan, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Tver', 170008

  • Novartis Investigative Site

    Velikiy Novgorod, 173016

  • Novartis Investigative Site

    Voronezh, 394062

  • Novartis Investigative Site

    Vsevolozhsk, 188663

Other trials in Russia

France15 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Bayonne, 64109

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Caen, 14076

  • Novartis Investigative Site

    Colmar, 68000

  • Novartis Investigative Site

    Dechy, 59187

  • Novartis Investigative Site

    Nancy, 54100

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Reims, 51056

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Saint-Grégoire, 35760

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Vannes, 56000

Other trials in France

Italy15 sites

  • Novartis Investigative Site

    Bologna, Emilia-Romagna, 40138

  • Novartis Investigative Site

    Bologna, Emilia-Romagna, 40139

  • Novartis Investigative Site

    Fermo (AP), The Marches, 63023

  • Novartis Investigative Site

    Lido Di Camaiore (LU), Tuscany, 55043

  • Novartis Investigative Site

    Meldola (FC), Emilia-Romagna, 47014

  • Novartis Investigative Site

    Monza, Lombardy, 20052

  • Novartis Investigative Site

    Novara, Piedmont, 28100

  • Novartis Investigative Site

    Perugia, Umbria, 06132

  • Novartis Investigative Site

    Pisa, Tuscany, 56126

  • Novartis Investigative Site

    Rimini, Emilia-Romagna, 47900

  • Novartis Investigative Site

    Rome, Lazio, 00144

  • Novartis Investigative Site

    Trento, Trentino-Alto Adige, 38100

  • Novartis Investigative Site

    Treviglio (BG), Lombardy, 24047

  • Novartis Investigative Site

    Udine, Friuli Venezia Giulia, 33100

  • Novartis Investigative Site

    Varese, 21100

Other trials in Italy

Poland9 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-796

  • Novartis Investigative Site

    Bytom, 41-902

  • Novartis Investigative Site

    Gliwice, 44-101

  • Novartis Investigative Site

    Konin, 62-500

  • Novartis Investigative Site

    Lodz, 93-509

  • Novartis Investigative Site

    Olsztyn, 10-228

  • Novartis Investigative Site

    Rzeszów, 35-021

  • Novartis Investigative Site

    Wroclaw, 51-124

  • Novartis Investigative Site

    Wroclaw, 53-413

Other trials in Poland

Greece7 sites

  • Novartis Investigative Site

    Athens, 115 26

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    N. Kifisia, Athens, 145 64

  • Novartis Investigative Site

    Neo Faliro, 18547

  • Novartis Investigative Site

    Pátrai, 26504

  • Novartis Investigative Site

    Peiraius, 185 37

  • Novartis Investigative Site

    Thessaloniki

Other trials in Greece

Hungary6 sites

  • Novartis Investigative Site

    Budapest, 1082

  • Novartis Investigative Site

    Budapest, 1122

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Tatabánya, 2800

  • Novartis Investigative Site

    Veszprém, 8200

Other trials in Hungary

Sweden4 sites

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Uppsala, SE-751 85

  • Novartis Investigative Site

    Västerås, SE-721 89

  • Novartis Investigative Site

    Vaxjo, SE-351 85

Other trials in Sweden

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Belgium3 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Brussels, 1180

  • Novartis Investigative Site

    Sint-Niklaas, 9100

Other trials in Belgium

Denmark1 site

  • Novartis Investigative Site

    Aarhus, 8000 Aarhus C

Other trials in Denmark

About this study

Official title: A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer

This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

Read the detailed description

The study was terminated based on the IDMC recommendation in 2012, collection of efficacy outcome measures was discontinued and all primary and secondary outcome measures were reported in 2012.

An amendment protocol allowed subjects who were on study treatment to enroll in a Long Term Follow Up (LTFU) phase if they had evidence of clinical benefit but no local access to standard of care treatments. Subjects received study treatment until disease progression, unacceptable toxicity, or subject withdrawal. In LTFU only Adverse Events data were collected. For the LTFU the Outcome Measure "Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2% of participants in either treatment arm" and "Adverse Events" were updated.

Being tested
capecitabine, lapatinib, trastuzumab
Keywords
ErbB2, HERCEPTIN, XELODA, ErbB1, TYKERB, metastatic breast cancer, trastuzumab, breast cancer, capecitabine, lapatinib, brain metastases, HER2 positive, TYVERB
Medical subject headings
Brain Neoplasms, Breast Neoplasms

What participants receive

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

  • capecitabineDrug

    oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle

  • lapatinibDrug

    oral medication; daily dose taken once a day

  • trastuzumabDrug

    infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks

Study groups in NCT00820222
Study groupRoleWhat they receive
Lapatinib plus capecitabineExperimentalLapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days
Receives: Drug: capecitabine; Drug: lapatinib
Trastuzumab plus capecitabineActive comparatortrastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days
Receives: Drug: capecitabine; Drug: trastuzumab

What is being measured

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

  1. Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse

    CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012

Secondary outcomes (10)

  1. Progression Free Survival (PFS), as Assessed by the Investigator

    PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012

  2. Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse

    CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.

    Measured: From randomization until the date of documented CNS progression (average of 10 months). Cut-off 11-Jun-2012

  3. Overall Survival

    Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.

    Measured: From randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012

  4. Number of Participants With Overall Response (OR), as Assessed by the Investigator

    OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesions or progression of existing bone lesions, even if the participant had no bone lesions present at Baseline. If a bone scan was performed at the time of initial response or near the time of response, the bone scan did not need to be repeated.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012

  5. Number of Participants With Clinical Benefit (CB)

    CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD [defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions] based on investigator assessment), for at least 24 weeks.

    Measured: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012

  6. Duration of Response

    Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.

    Measured: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months). Cut-off 11-Jun-2012

  7. Number of Participants With CNS Progression at Any Time

    CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.

    Measured: From the time of randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012

  8. Number of Participants With Qualitative and Quantitative Toxicities

    Qualitative and quantitative toxicities were measured as AEs. See the outcome measure entitled "Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2 participants in either treatment arm" and the AE module of this results summary for a list of AEs occurring in the study. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)

  9. Number of Participants Expressing Glucocorticoid Receptor, Phosphatase and Tensin Homolog (PTEN), Phosphatidylinositide 3-kinase (PI3K)/AKT, Protein 53 (P53), Insulin-like Growth Factor-1 (IGF-1), and Genes Involved in Cell Cycle Regulation

    Because the study terminated early, pharmacogenetic and biomarker analyses were not performed.

    Measured: Baseline

  10. Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2% of Participants in Either Treatment Arm

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. 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 the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months).

Timeline

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

  1. First posted12 Jan 2009 (estimated)
  2. Study start14 Apr 2009
  3. Primary completion11 Jun 2012
  4. Study completion22 Mar 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00820222
Sponsor's protocol ID
111438
Status last verified
Mar 2019
First submitted
8 Jan 2009
Last updated
2 Apr 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Pivot X, Manikhas A, Zurawski B, Chmielowska E, Karaszewska B, Allerton R, Chan S, Fabi A, Bidoli P, Gori S, Ciruelos E, Dank M, Hornyak L, Margolin S, Nusch A, Parikh R, Nagi F, DeSilvio M, Santillana S, Swaby RF, Semiglazov V. CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2015 May 10;33(14):1564-73. doi: 10.1200/JCO.2014.57.1794. Epub 2015 Jan 20.

    PubMed 25605838

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine, lapatinib and trastuzumab in people with Metastases, Brain, run by Novartis Pharmaceuticals at 164 sites in 14 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 10 inclusion and 17 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in Germany, Spain, United Kingdom, United States, Russia and 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Mar 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?

Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse (time frame: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012). 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 NCT00820222, 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 2 Apr 2019.

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