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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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 of Primary Interest (AEPIs)
Timepoint [1] 0 0
Baseline up to approximately 7 years
Secondary outcome [1] 0 0
Percentage of Participants With Specific AEPIs
Timepoint [1] 0 0
Baseline up to approximately 7 years
Secondary outcome [2] 0 0
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Timepoint [2] 0 0
Baseline up to approximately 7 years
Secondary outcome [3] 0 0
Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (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 7 years)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Baseline until death (up to approximately 7 years)
Secondary outcome [5] 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 [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 7 years)
Secondary outcome [6] 0 0
Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) 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 7 years)
Secondary outcome [7] 0 0
Duration of Response (DOR) According to RECIST v 1.1
Timepoint [7] 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 7 years)
Secondary outcome [8] 0 0
Time to Response According to RECIST v 1.1
Timepoint [8] 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 7 years)
Secondary outcome [9] 0 0
Number of Hospital Visits
Timepoint [9] 0 0
Baseline up to approximately 7 years
Secondary outcome [10] 0 0
Type of Hospital Visits
Timepoint [10] 0 0
Baseline up to approximately 7 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2020
Sample size
Target
Accrual to date
Final
2185
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
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
State/province [2] 0 0
La Rioja
Country [3] 0 0
Argentina
State/province [3] 0 0
Mar Del Plata
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
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Belgium
State/province [6] 0 0
Anderlecht
Country [7] 0 0
Belgium
State/province [7] 0 0
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
State/province [11] 0 0
Gent
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Belgium
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Leuven
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Belgium
State/province [13] 0 0
Liège
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Belgium
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Namur
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Belgium
State/province [15] 0 0
Wilrijk
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Brazil
State/province [16] 0 0
RJ
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Brazil
State/province [17] 0 0
RS
Country [18] 0 0
Brazil
State/province [18] 0 0
SC
Country [19] 0 0
Brazil
State/province [19] 0 0
SP
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Varna
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Newfoundland and Labrador
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Guangzhou
Country [28] 0 0
China
State/province [28] 0 0
Harbin
Country [29] 0 0
China
State/province [29] 0 0
Nanjing City
Country [30] 0 0
China
State/province [30] 0 0
Shanghai City
Country [31] 0 0
China
State/province [31] 0 0
Tianjin
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
Croatia
State/province [33] 0 0
Zagreb
Country [34] 0 0
Denmark
State/province [34] 0 0
Aalborg
Country [35] 0 0
Denmark
State/province [35] 0 0
Herlev
Country [36] 0 0
Denmark
State/province [36] 0 0
Hillerod
Country [37] 0 0
Denmark
State/province [37] 0 0
København Ø
Country [38] 0 0
Denmark
State/province [38] 0 0
Odense C
Country [39] 0 0
Denmark
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Roskilde
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Denmark
State/province [40] 0 0
Vejle
Country [41] 0 0
Dominican Republic
State/province [41] 0 0
Santiago
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Ecuador
State/province [42] 0 0
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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Amiens
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Angers
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Avignon
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Besançon
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Bordeaux
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Boulogne-billancourt
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Brest
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France
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Caen
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Clermont Ferrand
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Dijon
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France
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Grenoble
Country [60] 0 0
France
State/province [60] 0 0
Levallois Perret
Country [61] 0 0
France
State/province [61] 0 0
Lille
Country [62] 0 0
France
State/province [62] 0 0
Limoges
Country [63] 0 0
France
State/province [63] 0 0
Lorient
Country [64] 0 0
France
State/province [64] 0 0
Lyon
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France
State/province [65] 0 0
Marseille
Country [66] 0 0
France
State/province [66] 0 0
Mont-de-marsan
Country [67] 0 0
France
State/province [67] 0 0
Montpellier
Country [68] 0 0
France
State/province [68] 0 0
Nice
Country [69] 0 0
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State/province [69] 0 0
Paris
Country [70] 0 0
France
State/province [70] 0 0
Perigueux
Country [71] 0 0
France
State/province [71] 0 0
Perpignan
Country [72] 0 0
France
State/province [72] 0 0
Plerin
Country [73] 0 0
France
State/province [73] 0 0
Poitiers
Country [74] 0 0
France
State/province [74] 0 0
Reims CEDEX
Country [75] 0 0
France
State/province [75] 0 0
Reims
Country [76] 0 0
France
State/province [76] 0 0
Rennes
Country [77] 0 0
France
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Rouen
Country [78] 0 0
France
State/province [78] 0 0
Saint Herblain
Country [79] 0 0
France
State/province [79] 0 0
St Cloud
Country [80] 0 0
France
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Strasbourg
Country [81] 0 0
France
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Toulouse
Country [82] 0 0
France
State/province [82] 0 0
Tours
Country [83] 0 0
France
State/province [83] 0 0
Vandoeuvre-les-nancy
Country [84] 0 0
France
State/province [84] 0 0
Villejuif
Country [85] 0 0
Germany
State/province [85] 0 0
Augsburg
Country [86] 0 0
Germany
State/province [86] 0 0
Berlin
Country [87] 0 0
Germany
State/province [87] 0 0
Bottrop
Country [88] 0 0
Germany
State/province [88] 0 0
Dresden
Country [89] 0 0
Germany
State/province [89] 0 0
Erfurt
Country [90] 0 0
Germany
State/province [90] 0 0
Erlangen
Country [91] 0 0
Germany
State/province [91] 0 0
Hamburg
Country [92] 0 0
Germany
State/province [92] 0 0
Hannover
Country [93] 0 0
Germany
State/province [93] 0 0
Koblenz
Country [94] 0 0
Germany
State/province [94] 0 0
Leverkusen
Country [95] 0 0
Germany
State/province [95] 0 0
Muenchen
Country [96] 0 0
Germany
State/province [96] 0 0
Münster
Country [97] 0 0
Germany
State/province [97] 0 0
Offenbach
Country [98] 0 0
Germany
State/province [98] 0 0
Porta Westfalica
Country [99] 0 0
Germany
State/province [99] 0 0
Rostock
Country [100] 0 0
Germany
State/province [100] 0 0
Tübingen
Country [101] 0 0
Germany
State/province [101] 0 0
Wiesbaden
Country [102] 0 0
Germany
State/province [102] 0 0
Würzburg
Country [103] 0 0
Greece
State/province [103] 0 0
Crete
Country [104] 0 0
Greece
State/province [104] 0 0
Ioannina
Country [105] 0 0
Greece
State/province [105] 0 0
Patras
Country [106] 0 0
Greece
State/province [106] 0 0
Thessaloniki
Country [107] 0 0
Guatemala
State/province [107] 0 0
Guatemala
Country [108] 0 0
Hong Kong
State/province [108] 0 0
Hong Kong
Country [109] 0 0
Hong Kong
State/province [109] 0 0
Shatin
Country [110] 0 0
Hungary
State/province [110] 0 0
Budapest
Country [111] 0 0
Hungary
State/province [111] 0 0
Kaposvar
Country [112] 0 0
Iceland
State/province [112] 0 0
Reykjavik
Country [113] 0 0
Indonesia
State/province [113] 0 0
Jakarta
Country [114] 0 0
Ireland
State/province [114] 0 0
Cork
Country [115] 0 0
Ireland
State/province [115] 0 0
Dublin
Country [116] 0 0
Ireland
State/province [116] 0 0
Limerick
Country [117] 0 0
Italy
State/province [117] 0 0
Campania
Country [118] 0 0
Italy
State/province [118] 0 0
Emilia-Romagna
Country [119] 0 0
Italy
State/province [119] 0 0
Friuli-Venezia Giulia
Country [120] 0 0
Italy
State/province [120] 0 0
Lazio
Country [121] 0 0
Italy
State/province [121] 0 0
Liguria
Country [122] 0 0
Italy
State/province [122] 0 0
Lombardia
Country [123] 0 0
Italy
State/province [123] 0 0
Piemonte
Country [124] 0 0
Italy
State/province [124] 0 0
Puglia
Country [125] 0 0
Italy
State/province [125] 0 0
Sicilia
Country [126] 0 0
Italy
State/province [126] 0 0
Toscana
Country [127] 0 0
Italy
State/province [127] 0 0
Umbria
Country [128] 0 0
Italy
State/province [128] 0 0
Veneto
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Daegu
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Incheon
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Seoul
Country [132] 0 0
Luxembourg
State/province [132] 0 0
Luxembourg
Country [133] 0 0
Mexico
State/province [133] 0 0
Mexico CITY (federal District)
Country [134] 0 0
Mexico
State/province [134] 0 0
D.f.
Country [135] 0 0
Mexico
State/province [135] 0 0
DF
Country [136] 0 0
Mexico
State/province [136] 0 0
Mexico City
Country [137] 0 0
Netherlands
State/province [137] 0 0
Amsterdam
Country [138] 0 0
Netherlands
State/province [138] 0 0
Breda
Country [139] 0 0
Netherlands
State/province [139] 0 0
Den Haag
Country [140] 0 0
Netherlands
State/province [140] 0 0
Deventer
Country [141] 0 0
Netherlands
State/province [141] 0 0
Hengelo
Country [142] 0 0
Netherlands
State/province [142] 0 0
Hoofddorp
Country [143] 0 0
Netherlands
State/province [143] 0 0
Leeuwarden
Country [144] 0 0
Netherlands
State/province [144] 0 0
Sittard-Geleen
Country [145] 0 0
Netherlands
State/province [145] 0 0
Tilburg
Country [146] 0 0
Norway
State/province [146] 0 0
Oslo
Country [147] 0 0
Panama
State/province [147] 0 0
Panama
Country [148] 0 0
Peru
State/province [148] 0 0
Lima
Country [149] 0 0
Poland
State/province [149] 0 0
Bialystok
Country [150] 0 0
Poland
State/province [150] 0 0
Brzozów
Country [151] 0 0
Poland
State/province [151] 0 0
Kielce
Country [152] 0 0
Poland
State/province [152] 0 0
Kraków
Country [153] 0 0
Poland
State/province [153] 0 0
Otwock
Country [154] 0 0
Poland
State/province [154] 0 0
Rybnik
Country [155] 0 0
Portugal
State/province [155] 0 0
Lisboa
Country [156] 0 0
Portugal
State/province [156] 0 0
Porto
Country [157] 0 0
Slovakia
State/province [157] 0 0
Bratislava
Country [158] 0 0
Slovakia
State/province [158] 0 0
Trencin
Country [159] 0 0
Slovenia
State/province [159] 0 0
Ljubljana
Country [160] 0 0
Spain
State/province [160] 0 0
Alicante
Country [161] 0 0
Spain
State/province [161] 0 0
Asturias
Country [162] 0 0
Spain
State/province [162] 0 0
Barcelona
Country [163] 0 0
Spain
State/province [163] 0 0
Cadiz
Country [164] 0 0
Spain
State/province [164] 0 0
Cordoba
Country [165] 0 0
Spain
State/province [165] 0 0
Guipuzcoa
Country [166] 0 0
Spain
State/province [166] 0 0
Islas Baleares
Country [167] 0 0
Spain
State/province [167] 0 0
LAS Palmas
Country [168] 0 0
Spain
State/province [168] 0 0
Madrid
Country [169] 0 0
Spain
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Pontevedra
Country [170] 0 0
Spain
State/province [170] 0 0
Tarragona
Country [171] 0 0
Spain
State/province [171] 0 0
Vizcaya
Country [172] 0 0
Spain
State/province [172] 0 0
Caceres
Country [173] 0 0
Spain
State/province [173] 0 0
Girona
Country [174] 0 0
Spain
State/province [174] 0 0
Granada
Country [175] 0 0
Spain
State/province [175] 0 0
Jaen
Country [176] 0 0
Spain
State/province [176] 0 0
La Coruña
Country [177] 0 0
Spain
State/province [177] 0 0
Lerida
Country [178] 0 0
Spain
State/province [178] 0 0
Malaga
Country [179] 0 0
Spain
State/province [179] 0 0
Valencia
Country [180] 0 0
Spain
State/province [180] 0 0
Zaragoza
Country [181] 0 0
Sweden
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Stockholm
Country [182] 0 0
Sweden
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Umeå
Country [183] 0 0
Taiwan
State/province [183] 0 0
Tainan
Country [184] 0 0
Taiwan
State/province [184] 0 0
Taipei
Country [185] 0 0
Thailand
State/province [185] 0 0
Bangkok
Country [186] 0 0
Thailand
State/province [186] 0 0
Chiang Mai
Country [187] 0 0
Turkey
State/province [187] 0 0
Ankara
Country [188] 0 0
Turkey
State/province [188] 0 0
Gaziantep
Country [189] 0 0
Turkey
State/province [189] 0 0
Istanbul
Country [190] 0 0
Turkey
State/province [190] 0 0
Izmir
Country [191] 0 0
Turkey
State/province [191] 0 0
Izmit
Country [192] 0 0
United Arab Emirates
State/province [192] 0 0
Al Ain
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Aberdeen
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United Kingdom
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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/ct2/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
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01702571