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

Primary Purpose

Metastases, Brain

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

capecitabine

lapatinib

trastuzumab

About this trial

This is an interventional treatment trial for Metastases, Brain focused on measuring ErbB2, HERCEPTIN, XELODA, ErbB1, TYKERB, metastatic breast cancer, trastuzumab, breast cancer, capecitabine, lapatinib, brain metastases, HER2 positive, TYVERB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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;
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.

Exclusion Criteria:

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;
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lapatinib plus capecitabine

Trastuzumab plus capecitabine

Arm Description

Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days

trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00820222

First Posted

January 8, 2009

Last Updated

March 22, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00820222

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 14, 2009 (Actual)

Primary Completion Date

June 11, 2012 (Actual)

Study Completion Date

March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastases, Brain

Keywords

ErbB2, HERCEPTIN, XELODA, ErbB1, TYKERB, metastatic breast cancer, trastuzumab, breast cancer, capecitabine, lapatinib, brain metastases, HER2 positive, TYVERB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

540 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lapatinib plus capecitabine

Arm Type

Experimental

Arm Description

Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days

Arm Title

Trastuzumab plus capecitabine

Arm Type

Active Comparator

Arm Description

trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

lapatinib

Intervention Description

oral medication; daily dose taken once a day

Intervention Type

Drug

Intervention Name(s)

trastuzumab

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Overall Survival

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Participants With Clinical Benefit (CB)

Description

Time Frame

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

Title

Duration of Response

Description

Time Frame

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

Title

Number of Participants With CNS Progression at Any Time

Description

Time Frame

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

Title

Number of Participants With Qualitative and Quantitative Toxicities

Description

Time Frame

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

Title

Description

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

Time Frame

Baseline

Title

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

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85338

Country

United States

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Novartis Investigative Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Novartis Investigative Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novartis Investigative Site

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904-2007

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Novartis Investigative Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Novartis Investigative Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33065

Country

United States

Facility Name

Novartis Investigative Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Novartis Investigative Site

City

Warrenville

State/Province

Illinois

ZIP/Postal Code

60555

Country

United States

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Novartis Investigative Site

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1180

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

8000 Aarhus C

Country

Denmark

Facility Name

Novartis Investigative Site

City

Angers cedex 9

ZIP/Postal Code

49933

Country

France

Facility Name

Novartis Investigative Site

City

Avignon

ZIP/Postal Code

84000

Country

France

Facility Name

Novartis Investigative Site

City

Bayonne cedex

ZIP/Postal Code

64109

Country

France

Facility Name

Novartis Investigative Site

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Caen Cedex 05

ZIP/Postal Code

14076

Country

France

Facility Name

Novartis Investigative Site

City

Colmar

ZIP/Postal Code

68000

Country

France

Facility Name

Novartis Investigative Site

City

Dechy

ZIP/Postal Code

59187

Country

France

Facility Name

Novartis Investigative Site

City

Nancy

ZIP/Postal Code

54100

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Reims Cedex

ZIP/Postal Code

51056

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Novartis Investigative Site

City

Saint Priest En Jarez Cedex

ZIP/Postal Code

42271

Country

France

Facility Name

Novartis Investigative Site

City

Saint-Gregoire

ZIP/Postal Code

35760

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Novartis Investigative Site

City

Vannes

ZIP/Postal Code

56000

Country

France

Facility Name

Novartis Investigative Site

City

Ravensburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

88212

Country

Germany

Facility Name

Novartis Investigative Site

City

Eggenfelden

State/Province

Bayern

ZIP/Postal Code

84307

Country

Germany

Facility Name

Novartis Investigative Site

City

Fuerth

State/Province

Bayern

ZIP/Postal Code

90766

Country

Germany

Facility Name

Novartis Investigative Site

City

Landshut

State/Province

Bayern

ZIP/Postal Code

84028

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81925

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

State/Province

Bayern

ZIP/Postal Code

90449

Country

Germany

Facility Name

Novartis Investigative Site

City

Rosenheim

State/Province

Bayern

ZIP/Postal Code

83022

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97070

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

State/Province

Brandenburg

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

State/Province

Hessen

ZIP/Postal Code

65199

Country

Germany

Facility Name

Novartis Investigative Site

City

Bottrop

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

46236

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Goch

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47574

Country

Germany

Facility Name

Novartis Investigative Site

City

Herne

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44623

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50935

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51067

Country

Germany

Facility Name

Novartis Investigative Site

City

Velbert

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42551

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerselen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52146

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Speyer

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67346

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23562

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14169

Country

Germany

Facility Name

Novartis Investigative Site

City

Brandenburg

ZIP/Postal Code

14770

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28209

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 26

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Novartis Investigative Site

City

N. Kifisia, Athens

ZIP/Postal Code

145 64

Country

Greece

Facility Name

Novartis Investigative Site

City

Neo Faliro

ZIP/Postal Code

18547

Country

Greece

Facility Name

Novartis Investigative Site

City

Patra

ZIP/Postal Code

26504

Country

Greece

Facility Name

Novartis Investigative Site

City

Peiraius

ZIP/Postal Code

185 37

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1082

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Tatabanya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40139

Country

Italy

Facility Name

Novartis Investigative Site

City

Meldola (FC)

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

Novartis Investigative Site

City

Rimini

State/Province

Emilia-Romagna

ZIP/Postal Code

47900

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20052

Country

Italy

Facility Name

Novartis Investigative Site

City

Treviglio (BG)

State/Province

Lombardia

ZIP/Postal Code

24047

Country

Italy

Facility Name

Novartis Investigative Site

City

Fermo (AP)

State/Province

Marche

ZIP/Postal Code

63023

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Lido Di Camaiore (LU)

State/Province

Toscana

ZIP/Postal Code

55043

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Trento

State/Province

Trentino-Alto Adige

ZIP/Postal Code

38100

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06132

Country

Italy

Facility Name

Novartis Investigative Site

City

Varese

ZIP/Postal Code

21100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Novartis Investigative Site

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Novartis Investigative Site

City

Gliwice

ZIP/Postal Code

44-101

Country

Poland

Facility Name

Novartis Investigative Site

City

Konin

ZIP/Postal Code

62-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

Facility Name

Novartis Investigative Site

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Novartis Investigative Site

City

Rzeszow

ZIP/Postal Code

35-021

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Novartis Investigative Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kirov

ZIP/Postal Code

610021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow Region

ZIP/Postal Code

143 423

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhniy Novgorod

ZIP/Postal Code

603081

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Obninsk

ZIP/Postal Code

249036

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185035

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tver

ZIP/Postal Code

170008

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Velikiy Novgorod

ZIP/Postal Code

173016

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Voronezh

ZIP/Postal Code

394062

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Vsevolozhsk

ZIP/Postal Code

188663

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat (Barcelona)

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Jerez (Cadiz)

ZIP/Postal Code

11047

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

ZIP/Postal Code

15009

Country

Spain

Facility Name

Novartis Investigative Site

City

Lerida

ZIP/Postal Code

25198

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Torrevieja (Alicante)

ZIP/Postal Code

03186

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Vasteras

ZIP/Postal Code

SE-721 89

Country

Sweden

Facility Name

Novartis Investigative Site

City

Vaxjo

ZIP/Postal Code

SE-351 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Edinburgh

State/Province

Midlothian

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B18 7QH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Burton on Trent

ZIP/Postal Code

DE13 0RB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cottingham, Hull

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Huddersfield

ZIP/Postal Code

HD3 3EA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Ipswich

ZIP/Postal Code

IP4 5PD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Maidstone

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Peterborough

ZIP/Postal Code

PE3 9GZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Shrewsbury

ZIP/Postal Code

SY3 8XQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Worthing

ZIP/Postal Code

BN11 2DH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

25605838

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Metastases, Brain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial