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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01702571
Registration number
NCT01702571
Ethics application status
Date submitted
4/10/2012
Date registered
8/10/2012
Date last updated
4/04/2022
Titles & IDs
Public title
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
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Scientific title
A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment
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Secondary ID [1]
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2012-001628-37
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Secondary ID [2]
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MO28231
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab Emtansine
Experimental: Trastuzumab Emtansine (All Participants) - This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Experimental: Trastuzumab Emtansine (Asian Participants) - This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Treatment: Drugs: Trastuzumab Emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
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Assessment method [1]
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The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
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Timepoint [1]
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Baseline up to approximately 7 years
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Secondary outcome [1]
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Percentage of Participants With Specific AEPIs
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Assessment method [1]
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The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
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Timepoint [1]
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Baseline up to approximately 7 years
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Secondary outcome [2]
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Percentage of Participants With Adverse Events of Special Interest (AESIs)
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Assessment method [2]
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AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were \>3 × ULN, Concurrent elevation of total bilirubin \>2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin \>2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.
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Timepoint [2]
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Baseline up to approximately 7 years
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Secondary outcome [3]
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Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
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Assessment method [3]
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Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
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Timepoint [3]
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Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.
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Timepoint [4]
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Baseline until death (up to approximately 7 years)
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Secondary outcome [5]
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Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
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Assessment method [5]
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Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
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Timepoint [5]
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Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
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Secondary outcome [6]
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Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
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Assessment method [6]
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Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
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Timepoint [6]
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Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
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Secondary outcome [7]
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Duration of Response (DOR) According to RECIST v 1.1
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Assessment method [7]
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DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
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Timepoint [7]
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Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
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Secondary outcome [8]
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Time to Response According to RECIST v 1.1
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Assessment method [8]
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Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
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Timepoint [8]
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Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
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Secondary outcome [9]
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Number of Hospital Visits
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Assessment method [9]
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The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.
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Timepoint [9]
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Baseline up to approximately 7 years
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Secondary outcome [10]
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Type of Hospital Visits
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Assessment method [10]
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The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.
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Timepoint [10]
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Baseline up to approximately 7 years
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Eligibility
Key inclusion criteria
* HER2-positive disease determined locally
* Histologically or cytologically confirmed invasive breast cancer
* Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent
* Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy
* Measurable and/or non-measurable disease
* Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
* Adequate organ function
* Use of highly effective contraception as defined by the protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of treatment with trastuzumab emtansine
* Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
* Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0
* History of other malignancy within the previous 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
* History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
* History of exposure to cumulative doses of anthracyclines
* History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.
* Metastatic central nervous system (CNS) disease only
* Brain metastases which are symptomatic
* History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
* History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction or unstable angina within 6 months of first study treatment
* Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
* Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)
* Pregnancy or lactation
* Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
* History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2020
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Sample size
Target
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Accrual to date
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Final
2185
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research - North Sydney
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Recruitment hospital [2]
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Calvary Mater Newcastle; Medical Oncology - Waratah
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Recruitment hospital [3]
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Westmead Hospital; Medical Oncology and Pallative Care - Westmead
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Recruitment hospital [4]
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Haematology & Oncology Clinics of Australia Research Centre - South Brisbane
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Recruitment hospital [5]
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Ashford Cancer Center Research - Kurralta Park
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Recruitment hospital [6]
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Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
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Recruitment hospital [7]
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Sunshine Hospital; Oncology Research - St Albans
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Recruitment hospital [8]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2059 - North Sydney
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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5037 - Kurralta Park
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment postcode(s) [7]
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- St Albans
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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La Rioja
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Argentina
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Mar Del Plata
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Anderlecht
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Namur
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Belgium
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Wilrijk
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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Bulgaria
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Sofia
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Varna
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Guangzhou
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China
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Harbin
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China
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Nanjing City
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China
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Shanghai City
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China
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Tianjin
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China
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Zhejiang
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Croatia
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Zagreb
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Denmark
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Aalborg
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Herlev
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Denmark
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Hillerod
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Denmark
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København Ø
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Odense C
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Roskilde
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Vejle
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Dominican Republic
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Santiago
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Ecuador
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Guayaquil
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Ecuador
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Portoviejo
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Estonia
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Tallinn
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Tampere
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Finland
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Turku
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France
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Amiens
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France
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Angers
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Avignon
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Besançon
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Bordeaux
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Caen
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Clermont Ferrand
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Dijon
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Grenoble
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Levallois Perret
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Lille
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France
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Limoges
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France
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Lorient
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France
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Lyon
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Marseille
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Mont-de-marsan
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Montpellier
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Nice
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Perigueux
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Perpignan
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Plerin
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France
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Poitiers
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France
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Reims CEDEX
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France
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Reims
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France
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Rennes
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Rouen
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Saint Herblain
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France
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St Cloud
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France
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Strasbourg
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Toulouse
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Tours
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France
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Vandoeuvre-les-nancy
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Funding & Sponsors
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Commercial sector/industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.
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Trial website
https://clinicaltrials.gov/study/NCT01702571
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Trial related presentations / publications
Wuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7. Engebraaten O, Yau C, Berg K, Borgen E, Garred O, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z. Montemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Pena-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial?. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5.
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Public notes
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Contacts
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Hoffmann-La Roche
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/71/NCT01702571/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/71/NCT01702571/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01702571
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