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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/NCT01966471




Registration number
NCT01966471
Ethics application status
Date submitted
17/10/2013
Date registered
21/10/2013
Date last updated
14/06/2022

Titles & IDs
Public title
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
Scientific title
A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Secondary ID [1] 0 0
2012-004902-82
Secondary ID [2] 0 0
BO28407
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
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Epirubicin
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Docetaxel
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - 5-Fluorouracil

Active Comparator: Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane - Trastuzumab and pertuzumab will be administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.

Experimental: Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab - Trastuzumab emtansine and pertuzumab will continue for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.


Treatment: Drugs: Trastuzumab Emtansine
Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).

Treatment: Drugs: Trastuzumab
Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).

Treatment: Drugs: Pertuzumab
Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).

Treatment: Drugs: Paclitaxel
IV infusion of paclitaxel 80 mg/m^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.

Treatment: Drugs: Epirubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Treatment: Drugs: Doxorubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Treatment: Drugs: Docetaxel
IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter [mg/m^2] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m^2 in the first cycle and escalate to 100 mg/m^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.

Treatment: Drugs: Cyclophosphamide
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Treatment: Drugs: 5-Fluorouracil
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
Timepoint [1] 0 0
Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.
Primary outcome [2] 0 0
Invasive Disease-Free Survival (IDFS) in the Overall Population
Timepoint [2] 0 0
First participant randomized up to approximately 7.5 years
Secondary outcome [1] 0 0
IDFS Plus Second Primary Non-Breast Cancer
Timepoint [1] 0 0
Baseline up to approximately 70 months
Secondary outcome [2] 0 0
Disease-Free Survival (DFS)
Timepoint [2] 0 0
Baseline up to approximately 70 months
Secondary outcome [3] 0 0
Distant Recurrence-Free Interval (DRFI)
Timepoint [3] 0 0
Baseline up to approximately 70 months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
First participant randomized up to approximately 7.5 years
Secondary outcome [5] 0 0
Percentage of Participants With Adverse Events
Timepoint [5] 0 0
From randomization to approximately 7.5 years
Secondary outcome [6] 0 0
Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
Timepoint [6] 0 0
First participant randomized up to approximately 7.5 years.
Secondary outcome [7] 0 0
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
Timepoint [7] 0 0
Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
Secondary outcome [8] 0 0
EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
Timepoint [8] 0 0
Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
Secondary outcome [9] 0 0
Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
Timepoint [9] 0 0
From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(</=) 1

- Non-metastatic histologically confirmed primary invasive breast carcinoma that was
operable

- HER2-positive breast cancer

- Known hormone receptor status of the primary tumor

- Adequately excised: participants must have undergone either breast-conserving surgery
or mastectomy/nipple- or skin-sparing mastectomy

- Pathological tumor-node-metastasis staging (Union for International Cancer
Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible
participants must have either:

Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any
hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0
centimeters by standard local assessment and negative for estrogen receptor (ER) and
progesterone receptor (PR) determined by a central pathology laboratory

- Participants with synchronous bilateral invasive disease are eligible only if both
lesions are HER2-positive

- No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the
last surgery if additional resection required for breast cancer) and randomization

- Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram
(ECHO; preferred) or multiple-gated acquisition (MUGA) scans

- Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is
required

- Female participants of childbearing potential must be willing to use one highly
effective form of non-hormonal contraception or two effective forms of non-hormonal
contraception. For male participants with partners of childbearing potential, one
highly effective form of contraception or two effective forms of contraception must be
used. Contraception must continue for the duration of study treatment and for 6 months
after the last dose of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma

- History of non-breast malignancies within the 5 years prior to randomization, except
for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and
basal cell and squamous cell carcinomas of the skin

- Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC
7th edition, including inflammatory breast cancer

- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment
(for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy,
anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab,
lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR
anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the
time of primary surgery is acceptable)

- Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any
malignancy

- History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic
chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer
subsequently developed. Participants who had their DCIS/LCIS treated with surgery only
and/or contralateral DCIS treated with radiation are allowed to enter the study

- Participants with contraindication to RT while adjuvant RT is clinically indicated

- Concurrent anti-cancer treatment in another investigational trial

- Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring
anti-anginal medication, serious cardiac arrhythmia not controlled by adequate
medication, severe conduction abnormality, or clinically significant valvular disease,
significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac
arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to
randomization, uncontrolled hypertension, evidence of transmural infarction on
electrocardiogram (ECG), requirement for oxygen therapy

- Other concurrent serious diseases that may interfere with planned treatment, including
severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes,
or known infection with HIV

- Any known active liver disease. For participants who are known carriers of HBV/HCV,
active hepatitis B/C infection must be ruled out per local guidelines

- Inadequate hematologic, renal or liver function

- Pregnant or lactating women

- Hypersensitivity to any of the study medications or any of the ingredients or
excipients of these medications, including hypersensitivity to benzyl alcohol

- Chronic immunosuppressive therapies, including systemic corticosteroids

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
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
31/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/06/2021
Sample size
Target
Accrual to date
Final
1846
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [3] 0 0
Haematology & Oncology Clinics of Australia Research Centre - South Brisbane
Recruitment hospital [4] 0 0
Burnside War Memorial Hospital, Clinical Trials Centre - Adelaide
Recruitment hospital [5] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [6] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [7] 0 0
Epworth HealthCare; Clinical Trials Centre - Richmond
Recruitment hospital [8] 0 0
St John of God Murdoch Hospital; Oncology West - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5056 - Adelaide
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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North Carolina
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Washington
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Leuven
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Rennes
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Vandoeuvre-les-nancy
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Tbilisi
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Meiningen
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Muenchen
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Stralsund
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Troisdorf
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Weinheim
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Worms
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Guatemala
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Debrecen
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Italy
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Italy
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Puglia
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Italy
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Italy
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Umbria
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Veneto
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Aichi
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Ehime
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Fukuoka
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Gunma
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Hyogo
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Iwate
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Kagoshima
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Niigata
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Japan
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Okayama
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Saitama
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Shizuoka
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Tochigi
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Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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León
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Mexico
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Mexico City
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Mexico
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Monterrey
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Norway
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Oslo
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Norway
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Stavanger
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Panama
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Panama
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Peru
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Lima
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Peru
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Miraflores
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Pasay
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Philippines
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Quezon City
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Kraków
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Otwock
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Poland
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Warszawa
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
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Romania
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Iasi
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Russian Federation
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Ivanovo
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Orenburg
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Russian Federation
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Ryazan
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Russian Federation
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Yeovil

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

Ethics approval
Ethics application status

Summary
Brief summary
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety
of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination
with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth
(HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and
anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a
dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg)
intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at
a dose of 420 mg IV q3w in combination with a taxane.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01966471
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01966471