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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01702571




Registration number
NCT01702571
Ethics application status
Date submitted
4/10/2012
Date registered
8/10/2012
Date last updated
15/04/2020

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
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
Secondary ID [1] 0 0
2012-001628-37
Secondary ID [2] 0 0
MO28231
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events
Timepoint [1] 0 0
Baseline up to approximately 6 years
Secondary outcome [1] 0 0
Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
Timepoint [1] 0 0
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 6 years)
Secondary outcome [2] 0 0
Overall Survival According to RECIST v 1.1 As Per Investigator Assessment
Timepoint [2] 0 0
Baseline until death (Up to approximately 6 years)
Secondary outcome [3] 0 0
Percentage of Participants with Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
Timepoint [3] 0 0
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 6 years)
Secondary outcome [4] 0 0
Percentage of Participants with Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
Timepoint [4] 0 0
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 6 years)
Secondary outcome [5] 0 0
Duration of Response According to RECIST v 1.1
Timepoint [5] 0 0
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 6 years)
Secondary outcome [6] 0 0
Time to Response According to RECIST v 1.1
Timepoint [6] 0 0
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 6 years)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research - North Sydney
Recruitment hospital [2] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment hospital [4] 0 0
Haematology & Oncology Clinics of Australia Research Centre - South Brisbane
Recruitment hospital [5] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [7] 0 0
Sunshine Hospital; Oncology Research - St Albans
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2059 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
- St Albans
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
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Argentina
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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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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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RJ
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RS
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SC
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SP
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Sofia
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Varna
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British Columbia
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Newfoundland and Labrador
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Ontario
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Quebec
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Beijing
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China
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Guangzhou
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China
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Hangzhou
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China
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Harbin
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Nanjing
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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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Croatia
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Aalborg
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Herlev
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Hillerod
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Odense C
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Roskilde
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Lyon
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Tours
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Bottrop
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Hamburg
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Hannover
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Koblenz
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Germany
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Leverkusen
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Germany
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Muenchen
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Germany
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Münster
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Offenbach
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Germany
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Rostock
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Tübingen
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Germany
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Wiesbaden
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Germany
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Würzburg
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Greece
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Crete
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Greece
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Ioannina
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Greece
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Patras
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Greece
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Thessaloniki
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Guatemala
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Guatemala
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Budapest
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Hungary
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Kaposvar
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Iceland
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Indonesia
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Jakarta
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Ireland
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Cork
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Ireland
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Campania
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Veneto
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Luxembourg
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Luxembourg
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Mexico
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Mexico CITY (federal District)
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Mexico
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D.f.
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Mexico
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DF
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Mexico
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Mexico City
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Amsterdam
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Breda
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Den Haag
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Deventer
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Hengelo
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Hoofddorp
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Leeuwarden
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Netherlands
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Sittard-Geleen
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Netherlands
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Tilburg
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Norway
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Oslo
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Panama
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Panama
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Peru
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Lima
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Poland
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Bialystok
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Poland
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Brzozów
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Poland
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Kielce
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Kraków
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Otwock
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Rybnik
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Porto
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Trencin
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Alicante
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Barcelona
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Cadiz
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Cordoba
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LAS Palmas
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Madrid
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Tarragona
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Vizcaya
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Caceres
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Girona
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Granada
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Jaen
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Lerida
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Spain
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Malaga
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Stockholm
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Sweden
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Gaziantep
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Istanbul
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Izmir
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Turkey
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Izmit
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United Arab Emirates
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Coventry
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Eastbourne
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Epping
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Exeter
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State/province [200] 0 0
Glasgow
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Grimsby
Country [202] 0 0
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Huddersfield
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Hull
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Ipswich
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Lancaster
Country [206] 0 0
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London
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Maidstone
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Manchester
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Middlesex
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Plymouth
Country [211] 0 0
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Portsmouth
Country [212] 0 0
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Romford
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Sheffield
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Shrewsbury
Country [215] 0 0
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State/province [215] 0 0
Swansea
Country [216] 0 0
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State/province [216] 0 0
Yeovil
Country [217] 0 0
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State/province [217] 0 0
York
Country [218] 0 0
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State/province [218] 0 0
Barcelona
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Venezuela
State/province [219] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01702571
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications