A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
EMILIA
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
2 other identifiers
interventional
991
27 countries
323
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Feb 2009
Typical duration for phase_3 breast-cancer
323 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2009
CompletedFirst Posted
Study publicly available on registry
January 26, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedResults Posted
Study results publicly available
April 23, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 31, 2016
September 1, 2016
3.4 years
January 22, 2009
February 22, 2013
September 10, 2016
Conditions
Outcome Measures
Primary Outcomes (8)
Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants Who Died: Second Interim Analysis
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.
From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
Overall Survival: Second Interim Analysis (Co-primary Endpoint)
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.
From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
Percentage of Participants Who Died: Final Analysis
The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.
From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
Overall Survival: Final Analysis
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.
From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
Percentage of Participants Who Were Alive at Year 1
1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.
Year 1
Percentage of Participants Who Were Alive at Year 2
2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.
Year 2
Secondary Outcomes (9)
Percentage of Participants With PD or Death as Assessed by the Investigator
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
PFS as Assessed by the Investigator
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants With Objective Response (OR) as Assessed by an IRC
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Duration of Objective Response (DOR) as Assessed by an IRC
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants With Clinical Benefit as Assessed by an IRC
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- +4 more secondary outcomes
Study Arms (2)
Trastuzumab emtansine
EXPERIMENTALParticipants 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.
Lapatinib + Capecitabine
ACTIVE COMPARATORParticipants 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.
Interventions
Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.
Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.
Capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (323)
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Chandler, Arizona, 85224, United States
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Tucson, Arizona, 85719, United States
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Anaheim, California, 92801, United States
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Anaheim, California, 92807, United States
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Bakersfield, California, 93309, United States
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Baldwin Park, California, 91706, United States
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Bellflower, California, 90706, United States
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Duarte, California, 91010, United States
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Fontana, California, 92335, United States
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Hayward, California, 94545, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92093, United States
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La Mesa, California, 91942, United States
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Loma Linda, California, 92354, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90034, United States
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Los Angeles, California, 90057, United States
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Los Angeles, California, 90095-1772, United States
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Montebello, California, 90640, United States
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Newport Beach, California, 92660, United States
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Oakland, California, 94611, United States
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Panorama City, California, 91402, United States
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Riverside, California, 92505, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92120, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94115, United States
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San Jose, California, 95119, United States
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Santa Clara, California, 95051, United States
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Santa Maria, California, 93454, United States
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Santa Monica, California, 90404, United States
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South San Francisco, California, 94080, United States
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Thousand Oaks, California, 91360, United States
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Vallejo, California, 94589, United States
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Walnut Creek, California, 94596, United States
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Woodland Hills, California, 91367, United States
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Fort Collins, Colorado, 80528, United States
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Norwalk, Connecticut, 06856, United States
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Norwich, Connecticut, 06360, United States
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Stamford, Connecticut, 06902, United States
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Washington D.C., District of Columbia, 20010, United States
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Boca Raton, Florida, 33486, United States
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Fernandina Beach, Florida, 32034, United States
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Fort Lauderdale, Florida, 33316, United States
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Fort Myers, Florida, 33916, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32205, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32256, United States
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Jacksonville, Florida, 32258, United States
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Kissimmee, Florida, 34741, United States
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Lakeland, Florida, 33804-1057, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33176, United States
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Orange Park, Florida, 32073, United States
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Pembroke Pines, Florida, 33028, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30341, United States
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Atlanta, Georgia, 30342, United States
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Carrolton, Georgia, 30117, United States
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Cartersville, Georgia, 30121, United States
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Decatur, Georgia, 30033, United States
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Douglasville, Georgia, 30134, United States
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Macon, Georgia, 31217, United States
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Marietta, Georgia, 30060, United States
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Boise, Idaho, 83712, United States
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Meridian, Idaho, 83642, United States
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Nampa, Idaho, 83686, United States
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Post Falls, Idaho, 83854, United States
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Twin Falls, Idaho, 83301, United States
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Chicago, Illinois, 60612, United States
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Decatur, Illinois, 62526, United States
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Effingham, Illinois, 62526, United States
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Joliet, Illinois, 60435, United States
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Morris, Illinois, 60450, United States
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Peoria, Illinois, 61615-7828, United States
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Skokie, Illinois, 60076, United States
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Zion, Illinois, 60099, United States
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Bettendorf, Iowa, 52722, United States
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Wichita, Kansas, 67214-3728, United States
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Paducah, Kentucky, 42001, United States
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Covington, Louisiana, 70433, United States
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Lafayette, Louisiana, 70503, United States
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Marrero, Louisiana, 70072, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70115, United States
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Kittery, Maine, 03904, United States
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Wells, Maine, 04090, United States
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York Village, Maine, 03909, United States
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Baltimore, Maryland, 21202, United States
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Baltimore, Maryland, 21237, United States
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Bethesda, Maryland, 20817, United States
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Rockville, Maryland, 20850, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02118, United States
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Boston, Massachusetts, 02215, United States
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Burlington, Massachusetts, 01805, United States
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Peabody, Massachusetts, 01960, United States
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Brownstown, Michigan, 48183, United States
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Dearborn, Michigan, 48126, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Saint Joseph, Michigan, 49085, United States
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West Bloomfield, Michigan, 48322, United States
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Edina, Minnesota, 55414, United States
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Maplewood, Minnesota, 55109, United States
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Minneapolis, Minnesota, 55454, United States
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Saint Louis Park, Minnesota, 55426, United States
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Saint Paul, Minnesota, 55101, United States
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City of Saint Peters, Missouri, 63110, United States
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City of Saint Peters, Missouri, 63376, United States
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Joplin, Missouri, 64804, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59802, United States
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Omaha, Nebraska, 68114, United States
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Henderson, Nevada, 89052, United States
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Cherry Hill, New Jersey, 08002, United States
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Hackensack, New Jersey, 07601, United States
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Morristown, New Jersey, 07962, United States
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Parsippany, New Jersey, 07054, United States
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Voorhees Township, New Jersey, 08043, United States
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Santa Fe, New Mexico, 87505, United States
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Brockport, New York, 14420, United States
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Canandaigua, New York, 14424, United States
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Fresh Meadows, New York, 11366, United States
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Geneva, New York, 14456, United States
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Greece, New York, 14626, United States
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Lake Success, New York, 11042, United States
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Mount Kisco, New York, 10549, United States
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Rochester, New York, 14626, United States
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Stony Brook, New York, 11794, United States
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Charlotte, North Carolina, 28203, United States
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Durham, North Carolina, 27710, United States
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Hickory, North Carolina, 28602, United States
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Kinston, North Carolina, 28501, United States
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Washington, North Carolina, 27889, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43215, United States
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Columbus, Ohio, 43219, United States
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Columbus, Ohio, 43228, United States
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Middletown, Ohio, 45042, United States
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Newark, Ohio, 43055, United States
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Sandusky, Ohio, 44870, United States
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Portland, Oregon, 97227, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19124, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pittsburgh, Pennsylvania, 15232, United States
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East Providence, Rhode Island, 02915, United States
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Columbia, South Carolina, 29210, United States
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North Charleston, South Carolina, 29425, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78731, United States
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Bryan, Texas, 77802, United States
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Cypress, Texas, 77429, United States
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Dallas, Texas, 75230, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77090, United States
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Shenandoah, Texas, 77384, United States
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Temple, Texas, 76501, United States
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Fairfax, Virginia, 22031, United States
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Gig Harbor, Washington, 98332, United States
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Lakewood, Washington, 98499, United States
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Puyallup, Washington, 98372, United States
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Tacoma, Washington, 98405, United States
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Milwaukee, Wisconsin, 53226, United States
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Wausau, Wisconsin, 54401, United States
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Banja Luka, 78000, Bosnia and Herzegovina
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Sarajevo, 71000, Bosnia and Herzegovina
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Belo Horizonte, 30150-281, Brazil
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Curitiba, 80530-010, Brazil
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Goiânia, 74605-070, Brazil
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Itajaí, 88301-220, Brazil
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Jaú, 17210-080, Brazil
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João Pessoa, 58040280, Brazil
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Porto Alegre, 90430-090, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Porto Alegre - Rs, 90050-170, Brazil
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Rio de Janeiro, 20560-120, Brazil
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Rio de Janeiro, 22260-020, Brazil
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Santo André, 09060-870, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 1323020, Brazil
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Plovdiv, 4000, Bulgaria
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Sofia, 1756, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9002, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Vancouver, British Columbia, V5Z 1H5, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Greater Sudbury, Ontario, J9P 3Y1, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Bogotá, 0, Colombia
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Bogotá, 49 00, Colombia
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Montería, Colombia
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Copenhagen, 2100, Denmark
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Herlev, 2730, Denmark
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Odense, 5000, Denmark
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Helsinki, 00180, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Avignon, 84082, France
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Bordeaux, 33076, France
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Brest, 29609, France
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Caen, 14076, France
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Dijon, 21079, France
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La Roche-sur-Yon, 85925, France
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Montpellier, 34298, France
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Paris, 75248, France
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Saint-Brieuc, 22015, France
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Saint-Herblain, 44805, France
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Vandœuvre-lès-Nancy, 54511, France
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Aschaffenburg, 63739, Germany
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Berlin, 10367, Germany
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Berlin, 13125, Germany
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Berlin, 4169, Germany
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Bonn, 53113, Germany
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Dortmund, 44137, Germany
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Freiburg im Breisgau, 79106, Germany
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Fürstenwalde, 15517, Germany
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Hamburg, 20357, Germany
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Karlsruhe, 76135, Germany
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Kiel, 24105, Germany
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Offenbach, 63069, Germany
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Stralsund, 18435, Germany
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Hong Kong, Hong Kong
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Bangalore, 560027, India
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Gūrgaon, 122001, India
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Kolkata, 700 053, India
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New Delhi, 110029, India
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Pune, 411004, India
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Aviano, 33081, Italy
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Bologna, 40138, Italy
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Candiolo, 10060, Italy
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Genova, 16132, Italy
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Negrar, 37024, Italy
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Pisa, 56100, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Sassari, 07100, Italy
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Terni, 05100, Italy
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Acapulco, 39670, Mexico
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Oaxaca City, 68000, Mexico
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Toluca, 50180, Mexico
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Newtown, 6021, New Zealand
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Palmerston North, 4442, New Zealand
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Diliman, Quezon City, 1100, Philippines
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Quezon City, Luzon, 1101, Philippines
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Bialystok, 15-027, Poland
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Gdansk, 80-952, Poland
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Krakow, 31-531, Poland
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Lublin, 20-090, Poland
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Opole, 45-060, Poland
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Poznan, 61-866, Poland
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Warsaw, 02-781, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4200-072, Portugal
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Kemerovo, 650036, Russia
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Moscow, 121356, Russia
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Saint Petersburg, 197758, Russia
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Singapore, 119074, Singapore
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Singapore, 169610, Singapore
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Ljubljana, 1000, Slovenia
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Kyunggi-do, 411-769, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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Lleida, 25198, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Zaragoza, 50009, Spain
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Eskilstuna, 63188, Sweden
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Gaelve, 80187, Sweden
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Gothenburg, 40036, Sweden
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Lucerne, 6004, Switzerland
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Sankt Gallen, 9007, Switzerland
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Kaohsung, 883, Taiwan
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Taichung, 404, Taiwan
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Taichung, 407, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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Bournemouth, BH7 7DW, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Denbigh, LL18 5UJ, United Kingdom
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London, SE1 7EH, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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New Castle Upon Tyne, NE7 7DN, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Poole, BH15 2JB, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Romford, RM7 0AG, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Weston-super-Mare, BS23 4TQ, United Kingdom
Related Publications (3)
Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16.
PMID: 28526536DERIVEDVerma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1.
PMID: 23020162DERIVEDScott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.
PMID: 22437872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2009
First Posted
January 26, 2009
Study Start
February 1, 2009
Primary Completion
July 1, 2012
Study Completion
September 1, 2015
Last Updated
October 31, 2016
Results First Posted
April 23, 2013
Record last verified: 2016-09