Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00829166
First received: January 22, 2009
Last updated: September 10, 2016
Last verified: September 2016
  Purpose
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Condition Intervention Phase
Breast Cancer
Drug: Trastuzumab emtansine
Drug: Lapatinib
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.

  • Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.

  • Percentage of Participants Who Died: Second Interim Analysis [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) ] [ Designated as safety issue: No ]
    The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.

  • Overall Survival: Second Interim Analysis (Co-primary Endpoint) [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.

  • Percentage of Participants Who Died: Final Analysis [ Time Frame: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) ] [ Designated as safety issue: No ]
    The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.

  • Overall Survival: Final Analysis [ Time Frame: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.

  • Percentage of Participants Who Were Alive at Year 1 [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
    1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.

  • Percentage of Participants Who Were Alive at Year 2 [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
    2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.


Secondary Outcome Measures:
  • Percentage of Participants With PD or Death as Assessed by the Investigator [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.

  • PFS as Assessed by the Investigator [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.

  • Percentage of Participants With Objective Response (OR) as Assessed by an IRC [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.

  • Duration of Objective Response (DOR) as Assessed by an IRC [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.

  • Percentage of Participants With Clinical Benefit as Assessed by an IRC [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.

  • Percentage of Participants With Treatment Failure [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported.

  • Time to Treatment Failure [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.

  • Percentage of Participants With Symptom Progression [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported.

  • Time to Symptom Progression [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ] [ Designated as safety issue: No ]
    Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.


Enrollment: 991
Study Start Date: February 2009
Study Completion Date: September 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Drug: Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.
Other Names:
  • T-DM1
  • Trastuzumab-MCC-DM1
  • RO5304020
Active Comparator: Lapatinib + Capecitabine
Participants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine.
Drug: Lapatinib
Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.
Other Names:
  • Tykerb
  • Tyverb
Drug: Capecitabine
Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
  • Histologically or cytologically confirmed invasive breast cancer
  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent
  • Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
  • Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
  • Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment

Exclusion Criteria:

  • History of treatment with trastuzumab emtansine
  • Prior treatment with lapatinib or capecitabine
  • Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0
  • History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
  • History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria
  • History of radiation therapy within 14 days of randomization
  • Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
  • History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction or unstable angina within 6 months of randomization
  • Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
  • Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Pregnancy or lactation
  • Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
  • Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
  • History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab
  • Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency
  • Current treatment with sorivudine or its chemically related analogs, such as brivudine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829166

  Hide Study Locations
Locations
United States, Arizona
Chandler, Arizona, United States, 85224
Tucson, Arizona, United States, 85719
United States, California
Anaheim, California, United States, 92801
Anaheim, California, United States, 92807
Bakersfield, California, United States, 93309
Baldwin Park, California, United States, 91706
Bellflower, California, United States, 90706
Duarte, California, United States, 91010
Fontana, California, United States, 92335
Hayward, California, United States, 94545
Irvine, California, United States, 92618
La Jolla, California, United States, 92093
La Mesa, California, United States, 91942
Loma Linda, California, United States, 92354
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90025
Los Angeles, California, United States, 90034
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095-1772
Montebello, California, United States, 90640
Newport Beach, California, United States, 92660
Oakland, California, United States, 94611
Panorama City, California, United States, 91402
Riverside, California, United States, 92505
Roseville, California, United States, 95661
Sacramento, California, United States, 95825
San Diego, California, United States, 92120
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
San Jose, California, United States, 95119
Santa Clara, California, United States, 95051
Santa Maria, California, United States, 93454
Santa Monica, California, United States, 90404
South San Francisco, California, United States, 94080
Thousand Oaks, California, United States, 91360
Vallejo, California, United States, 94589
Walnut Creek, California, United States, 94596
Woodland Hills, California, United States, 91367
United States, Colorado
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Norwalk, Connecticut, United States, 06856
Norwich, Connecticut, United States, 06360
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Boca Raton, Florida, United States, 33486
Fernandina Beach, Florida, United States, 32034
Fort Myers, Florida, United States, 33916
Ft. Lauderdale, Florida, United States, 33316
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32207
Jacksonville, Florida, United States, 32256
Jacksonville, Florida, United States, 32258
Kissimmee, Florida, United States, 34741
Lakeland, Florida, United States, 33804-1057
Miami, Florida, United States, 33133
Miami, Florida, United States, 33136
Miami, Florida, United States, 33176
Orange Park, Florida, United States, 32073
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Athens, Georgia, United States, 30607
Atlanta, Georgia, United States, 30318
Atlanta, Georgia, United States, 30322
Atlanta, Georgia, United States, 30341
Atlanta, Georgia, United States, 30342
Carrolton, Georgia, United States, 30117
Cartersville, Georgia, United States, 30121
Decatur, Georgia, United States, 30033
Douglasville, Georgia, United States, 30134
Macon, Georgia, United States, 31217
Marietta, Georgia, United States, 30060
United States, Idaho
Boise, Idaho, United States, 83712
Meridian, Idaho, United States, 83642
Nampa, Idaho, United States, 83686
Post Falls, Idaho, United States, 83854
Twin Falls, Idaho, United States, 83301
United States, Illinois
Chicago, Illinois, United States, 60612
Decatur, Illinois, United States, 62526
Effingham, Illinois, United States, 62526
Joliet, Illinois, United States, 60435
Morris, Illinois, United States, 60450
Peoria, Illinois, United States, 61615-7828
Skokie, Illinois, United States, 60076
Zion, Illinois, United States, 60099
United States, Iowa
Bettendorf, Iowa, United States, 52722
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
Paducah, Kentucky, United States, 42001
United States, Louisiana
Covington, Louisiana, United States, 70433
Lafayette, Louisiana, United States, 70503
Marrero, Louisiana, United States, 70072
Metairie, Louisiana, United States, 70006
New Orleans, Louisiana, United States, 70115
United States, Maine
Kittery, Maine, United States, 03904
Wells, Maine, United States, 04090
York, Maine, United States, 03909
United States, Maryland
Baltimore, Maryland, United States, 21202
Baltimore, Maryland, United States, 21237
Bethesda, Maryland, United States, 20817
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02118
Boston, Massachusetts, United States, 02215
Burlington, Massachusetts, United States, 01805
Peabody, Massachusetts, United States, 01960
United States, Michigan
Brownstown, Michigan, United States, 48183
Dearborn, Michigan, United States, 48126
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
Saint Joseph, Michigan, United States, 49085
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Edina, Minnesota, United States, 55414
Maplewood, Minnesota, United States, 55109
Minneapolis, Minnesota, United States, 55454
Saint Louis Park, Minnesota, United States, 55426
Saint Paul, Minnesota, United States, 55101
St. Louis Park, Minnesota, United States, 55426
United States, Missouri
Joplin, Missouri, United States, 64804
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63110
Saint Peters, Missouri, United States, 63110
St. Louis, Missouri, United States, 63141
St. Peters, Missouri, United States, 63376
United States, Montana
Missoula, Montana, United States, 59802
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Cherry Hill, New Jersey, United States, 08002
Hackensack, New Jersey, United States, 07601
Morristown, New Jersey, United States, 07962
Parsippany, New Jersey, United States, 07054
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Brockport, New York, United States, 14420
Canandaigua, New York, United States, 14424
Fresh Meadows, New York, United States, 11366
Geneva, New York, United States, 14456
Greece, New York, United States, 14626
Lake Success, New York, United States, 11042
Mount Kisco, New York, United States, 10549
Rochester, New York, United States, 14626
Stony Brook, New York, United States, 11794
United States, North Carolina
Charlotte, North Carolina, United States, 28203
Durham, North Carolina, United States, 27710
Hickory, North Carolina, United States, 28602
Kinston, North Carolina, United States, 28501
Washington, North Carolina, United States, 27889
United States, Ohio
Cleveland, Ohio, United States, 44106
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43215
Columbus, Ohio, United States, 43219
Columbus, Ohio, United States, 43228
Middletown, Ohio, United States, 45042
Newark, Ohio, United States, 43055
Sandusky, Ohio, United States, 44870
United States, Oregon
Portland, Oregon, United States, 97227
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Philadelphia, Pennsylvania, United States, 19124
Pittsburgh, Pennsylvania, United States, 15213
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
East Providence, Rhode Island, United States, 02915
United States, South Carolina
Columbia, South Carolina, United States, 29210
North Charleston, South Carolina, United States, 29425
United States, Tennessee
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78731
Bryan, Texas, United States, 77802
Cypress, Texas, United States, 77429
Dallas, Texas, United States, 75230
El Paso, Texas, United States, 79902
Houston, Texas, United States, 77090
Shenandoah, Texas, United States, 77384
Temple, Texas, United States, 76501
United States, Virginia
Fairfax, Virginia, United States, 22031
United States, Washington
Gig Harbor, Washington, United States, 98332
Lakewood, Washington, United States, 98499
Puyallup, Washington, United States, 98372
Tacoma, Washington, United States, 98405
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Wausau, Wisconsin, United States, 54401
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajewo, Bosnia and Herzegovina, 71000
Brazil
Belo Horizonte, Brazil, 30150-281
Curitiba, Brazil, 80530-010
Goiania, Brazil, 74605-070
Itajai, Brazil, 88301-220
JAU, Brazil, 17210-080
Joao Pessoa, Brazil, 58040280
Porto Alegre - Rs, Brazil, 90050-170
Porto Alegre, Brazil, 90430-090
Porto Alegre, Brazil, 90610-000
Porto Alegre, Brazil, 91350-200
Rio de Janeiro, Brazil, 20560-120
Rio de Janeiro, Brazil, 22260-020
Santo Andre, Brazil, 09060-870
Sao Paulo, Brazil, 01317-000
Sao Paulo, Brazil, 1323020
Bulgaria
Plovdiv, Bulgaria, 4000
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1784
Varna, Bulgaria, 9002
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver, British Columbia, Canada, V5Z 1H5
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Sudbury, Ontario, Canada, J9P 3Y1
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H3T 1E2
Colombia
Bogota, Colombia, 0
Bogota, Colombia, 49 00
Monteria, Colombia
Denmark
Herlev, Denmark, 2730
København, Denmark, 2100
Odense, Denmark, 5000
Finland
Helsinki, Finland, 00180
Tampere, Finland, 33520
Turku, Finland, 20520
France
Avignon, France, 84082
Bordeaux, France, 33076
Brest, France, 29609
Caen, France, 14076
Dijon, France, 21079
La Roche Sur Yon, France, 85925
Montpellier, France, 34298
Paris, France, 75248
Saint Brieuc, France, 22015
Saint Herblain, France, 44805
Vandoeuvre-les-nancy, France, 54511
Germany
Aschaffenburg, Germany, 63739
Berlin, Germany, 10367
Berlin, Germany, 13125
Berlin, Germany, 4169
Bonn, Germany, 53113
Dortmund, Germany, 44137
Freiburg, Germany, 79106
Fuerstenwalde, Germany, 15517
Hamburg, Germany, 20357
Karlsruhe, Germany, 76135
Kiel, Germany, 24105
Offenbach, Germany, 63069
Stralsund, Germany, 18435
Hong Kong
Hong Kong, Hong Kong
India
Bangalore, India, 560027
Gurgaon, India, 122001
Kolkata, India, 700 053
New Delhi, India, 110029
Pune, India, 411004
Italy
Aviano, Italy, 33081
Bologna, Italy, 40138
Candiolo, Italy, 10060
Genova, Italy, 16132
Meldola, Italy, 47014
Milano, Italy, 20133
Milano, Italy, 20141
Napoli, Italy, 80131
Negrar, Italy, 37024
Pisa, Italy, 56100
Reggio Emilia, Italy, 42100
Roma, Italy, 00168
Rozzano, Italy, 20089
Sassari, Italy, 07100
Terni, Italy, 05100
Korea, Republic of
Kyunggi-do, Korea, Republic of, 411-769
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Mexico
Acapulco, Mexico, 39670
Oaxaca, Mexico, 68000
Toluca, Mexico, 50180
New Zealand
Newtown, New Zealand, 6021
Palmerston North, New Zealand, 4442
Philippines
Diliman, Quezon City, Philippines, 1100
Quezon City, Luzon, Philippines, 1101
Poland
Bialystok, Poland, 15-027
Gdansk, Poland, 80-952
Krakow, Poland, 31-531
Lublin, Poland, 20-090
Opole, Poland, 45-060
Poznan, Poland, 61-866
Warszawa, Poland, 02-781
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1649-035
Porto, Portugal, 4200-072
Russian Federation
Kemerovo, Russian Federation, 650036
Moscow, Russian Federation, 121356
St Petersburg, Russian Federation, 197758
Singapore
Singapore, Singapore, 119074
Singapore, Singapore, 169610
Slovenia
Ljubljana, Slovenia, 1000
Spain
Barcelona, Spain, 08035
Córdoba, Spain, 14004
Lerida, Spain, 25198
Madrid, Spain, 28041
Madrid, Spain, 28046
Santander, Spain, 39008
Sevilla, Spain, 41013
Valencia, Spain, 46009
Zaragoza, Spain, 50009
Sweden
Eskilstuna, Sweden, 63188
Gaelve, Sweden, 80187
Goteborg, Sweden, 40036
Switzerland
Luzern, Switzerland, 6004
St. Gallen, Switzerland, 9007
Taiwan
Kaohsung, Taiwan, 883
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
United Kingdom
Bournemouth, United Kingdom, BH7 7DW
Cardiff, United Kingdom, CF14 2TL
Denbigh, United Kingdom, LL18 5UJ
London, United Kingdom, SE1 7EH
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M20 4BX
New Castle Upon Tyne, United Kingdom, NE7 7DN
Northwood, United Kingdom, HA6 2RN
Poole, United Kingdom, BH15 2JB
Preston, United Kingdom, PR2 9HT
Romford, United Kingdom, RM7 0AG
Sutton, United Kingdom, SM2 5PT
Weston Super Mare, United Kingdom, BS23 4TQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00829166     History of Changes
Other Study ID Numbers: BO21977  TDM4370g 
Study First Received: January 22, 2009
Results First Received: February 22, 2013
Last Updated: September 10, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Ado-trastuzumab emtansine
Trastuzumab
Capecitabine
Maytansine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 08, 2016