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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01160211




Registration number
NCT01160211
Ethics application status
Date submitted
1/07/2010
Date registered
12/07/2010
Date last updated
18/06/2020

Titles & IDs
Public title
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
Scientific title
A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies
Secondary ID [1] 0 0
2010-019577-16
Secondary ID [2] 0 0
114299
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lapatinib
Treatment: Drugs - trastuzumab
Treatment: Drugs - Aromatase inhibitor
Treatment: Drugs - lapatinib

Experimental: Lapatinib plus trastuzumab plus aromatase inhibitor - Experimental

Active Comparator: trastuzmab plus aromatase inhibitor - Active Comparator

Active Comparator: lapatinib plus aromatase inhibitor - Active Comparator


Treatment: Drugs: lapatinib
1000 mg by mouth once a day

Treatment: Drugs: trastuzumab
Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks

Treatment: Drugs: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily

Treatment: Drugs: lapatinib
1500 mg by mouth once daily

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

Outcomes
Primary outcome [1] 0 0
PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination - Progression free survival (PFS) of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination. PFS is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor.
Timepoint [1] 0 0
approximately 5 years
Primary outcome [2] 0 0
Median Kaplan Meier Estimates for PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination - Progression free survival (PFS) of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination. PFS is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor.
Timepoint [2] 0 0
approximately 5 years
Secondary outcome [1] 0 0
PFS of Trastuzumab/AI vs. Lapatinib/AI and Trastuzumab/Lapatinib/AI vs. Lapatinib/AI - PFS in the lapatinib arm vs. the trastuzumab arm and in the lapatinib+trastuzumab arm vs. the lapatinib arm.
Timepoint [1] 0 0
approximately 5 years
Secondary outcome [2] 0 0
Overall Survival (OS) Events of Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI - OS was defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For subjects who did not die during the study, death was censored at the date of last contact.
Timepoint [2] 0 0
approximately 5 years
Secondary outcome [3] 0 0
Overall Response Rate (ORR; Complete or Partial Response) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI - The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence & was determined programmatically using investigators assessment of responses of target lesion, non-target lesion and new lesions based on RECIST v1.1. CR=disappearance of all target lesion & non-target lesions, if applicable, and no new lesion; PR = =30% decrease in the sum of the longest diameter of target lesions & non-target lesion was neither non-CR nor progressive disease (Non-PD) or not evaluable (NE); stable disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD should maintain for at least 56 days); PD = =20% increase from nadir (smallest sum diameters recorded since treatment start) of the target lesions and/or any status for non-target lesions or appearance of new lesion; NE = cannot be classified by the above definitions. Overall Response (OR) = CR + PR.
Timepoint [3] 0 0
approximately 5 years
Secondary outcome [4] 0 0
Clinical Benefit Rate (CBR; Complete Response, Partial Response, or Stable Disease for at Least 6 Months) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI - Clinical Benefit Rate (CBR) was defined as the percentage of patients with evidence of complete response (CR) or partial response (PR) at any time or maintaining SD for at least 24 weeks while on study, according to the investigator assessment of response per RECIST 1.1 criteria.
Timepoint [4] 0 0
approximately 5 years
Secondary outcome [5] 0 0
Duration of Response in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI - Kaplan-Meier estimates for duration of response in lapatinib+trastuzumab+AI vs. trastuzumab+AI and lapatinib+AI vs. trastuzumab+AI. Duration of response is defined as the time from first documented Complete Response or Partial Response until the first documented sign of Progressive Disease or Death, or to the date of censor.
Timepoint [5] 0 0
approximately 5 years
Secondary outcome [6] 0 0
Changes in the Quality of Life (QoL) Status Relative to Baseline FACT-B Overall and Subscale Scores at Last On-treatment Assessment - Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. It is a 37-item (27 general questions and 10 breast cancer specific questions) self-reporting instrument consisting of 5 dimensions: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The followings are the score ranges for each self-reporting subscale: • PWB : 0-28 • SWB : 0-28 • EWB : 0-24 • FWB : 0-28 • BCS : 0-40 FACT-B Total Outcome Index (TOI) = PWB + FWB + BCS (range:0 - 96) FACT-B Total Score = PWB + SWB + EWB + FWB + BCS (range:0-148) FACT-G Total Score = PWB + SWB + EWB + FWB (range:0-108) In the scoring system, negative stated items are reversed by subtracting the response from "4" and after reversing proper items, all subscale items are summed to a total, which is the subscale score. For all the FACIT scales and symptom indices, the higher the score the better cut off
Timepoint [6] 0 0
approximately 5 years
Secondary outcome [7] 0 0
Time to Response in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI - Time to response in lapatinib+trastuzumab+AI vs. trastuzumab+AI and lapatinib+AI vs. trastuzumab+AI. Time to response is defined as time from randomization to first documented Complete Response or Partial Response.
Timepoint [7] 0 0
approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

Subjects eligible for enrollment in the study must meet all of the following criteria:

1. Signed written informed consent. In Korea and Japan, subjects between >=18 and <20
years of age must also have a legal representative sign the written informed consent.

2. Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any
of the following:

- Subjects at least 60 years of age.

- Subjects under 60 years of age and amenorrhic for at least 12 consecutive months
AND follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal
range (utilizing ranges from the local laboratory facility).

- Prior bilateral oophorectomy.

- Prior radiation castration with amenorrhea for at least 6 months

3. Subjects must have a history of histologically confirmed breast cancer, with a
clinically confirmed diagnosis of metastatic disease [confirmed by histology, cytology
or other clinical means (e.g. CT, MRI)]. Subjects may have either measurable or
non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

4. Tumors that are ER+ and/or PgR+ by local laboratory

5. Documentation of HER2 overexpression or gene amplification, in the invasive component
of either the primary tumor or metastatic disease site as defined as:

- 3+ by Immunohistochemistry (IHC) and/or

- HER2/neu gene amplification by fluorescence, chromogenic or silver in situ
hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH,
CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of =2.0]

6. Subject must have received at least one prior regimen containing trastuzumab in
combination with chemotherapy for breast cancer:.

- Subject has ONLY received prior trastuzumab in combination with chemotherapy as
neoadjuvant and/or adjuvant treatment. OR

- Subject has received ONE prior trastuzumab-containing regimen for metastatic
disease (and has progressed), and may or may not have received prior trastuzumab
in combination with chemotherapy as neoadjuvant and/or adjuvant treatment.

7. Subject must have received prior endocrine therapy (such as aromatase inhibitors or
selective estrogen receptor modulators). 8. Subjects who have a life expectancy of > 6
months as assessed by the treating investigator

9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) =50% measured by
echocardiography (ECHO) or multi-gated acquisition scan (MUGA) 10. Subject must have an
ECOG performance status of 0-1 11. All prior treatment related toxicities must be CTCAE
(Version 4.0) = Grade 1 at the time of randomization 12. Completion of screening
assessments 13. Adequate baseline organ function. 14. Subjects must meet all of the
following criteria:

- QTc <450msec or

- QTc <480msec for subjects with bundle branch block The QTc is the QT interval
corrected for heart rate according to either Bazett's formula (QTcB) or to
Fridericia's formula (QTcF), machine or manual over read, for males and females. The
specific formula that will be used in a protocol should be determined prior to
initiation of the study, and the formula used to determine inclusion and
discontinuation should be the same throughout the study. The QTc should be based on
single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a
brief recording period
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. History of another malignancy. Exception: Subjects who have been disease-free for 5
years, or subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible.

2. Subjects with extensive symptomatic visceral disease including hepatic involvement and
pulmonary lymphangitic spread of tumor, or the disease is considered by the
investigator to be rapidly progressing or life threatening (subjects who are intended
for chemotherapy)

3. Serious cardiac illness or medical condition including but not confined to:

- Uncontrolled arrhythmias

- Uncontrolled or symptomatic angina

- History of congestive heart failure (CHF)

- Documented myocardial infarction <6 months from study entry

4. Known history of, or clinical evidence of, central nervous system (CNS) metastases or
leptomeningeal carcinomatosis

5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease
(with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones,
liver metastases or stable chronic liver disease per investigator assessment)

6. Have a concurrent disease or condition that may interfere with study participation, or
any serious medical disorder that would interfere with the subject's safety (for
example, active or uncontrolled infection or any psychiatric condition prohibiting
understanding or rendering of informed consent)

7. Have any clinically significant gastrointestinal abnormalities that may alter
absorption such as malabsorption syndrome or major resection of the stomach or bowels

8. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to any of the study agents or their excipients that, in the opinion
of the Investigator or GSK medical monitor, contraindicates their participation

9. Any prohibited medication.

10. Administration of an investigational drug within 30 days or 5 half-lives, whichever is
longer, preceding the first dose of study treatment.

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
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)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Wodonga
Recruitment hospital [3] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [4] 0 0
Novartis Investigative Site - Douglas
Recruitment hospital [5] 0 0
Novartis Investigative Site - Ringwood East
Recruitment hospital [6] 0 0
Novartis Investigative Site - Tweed Heads
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3690 - Wodonga
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
3135 - Ringwood East
Recruitment postcode(s) [6] 0 0
2485 - Tweed Heads
Recruitment outside Australia
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United States of America
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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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Iowa
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Michigan
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Minnesota
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Montana
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Nebraska
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North Carolina
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Ohio
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Río Negro
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Argentina
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Santa Fe
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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La Rioja
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Quilmes
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Leuven
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Jilin
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Harbin
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Osijek
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Pula
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Croatia
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Zagreb
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Bayern
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Niedersachsen
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Sachsen-Anhalt
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Schleswig-Holstein
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Berlin
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Hamburg
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Greece
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Athens
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Greece
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Chania
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Greece
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Heraklion
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Greece
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Perioxi Dragana, Alexandroupolis
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Pokfulam
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Tuen Mun
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Budapest
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Debrecen
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Gyor
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Gyula
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Kaposvar
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Miskolc
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Hungary
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Nyiregyhaza
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Pecs
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Szeged
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Hungary
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Szolnok
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Hungary
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Veszprem
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Hungary
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Zalaegerszeg
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India
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Bangalore
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India
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Chennai
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India
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Delhi
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India
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Nagpur
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India
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New Delhi
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India
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Pune
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India
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Surat
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Ireland
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Dublin 7
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Ireland
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Dublin
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Ireland
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Galway
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah-Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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San Giovanni Rotondo
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Kagoshima
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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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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Lithuania
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Vilnius
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Norway
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Lorenskog
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Peru
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Lima
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Peru
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Arequipa
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Peru
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Trujillo
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Philippines
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Makati City
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Philippines
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Quezon City
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Poland
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Konin
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Poland
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Lubin
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Poland
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Otwock
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Poland
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Warszawa
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Poland
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Wieliszew
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Poland
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Evora
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Puerto Rico
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San Juan
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Timisoara
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Russian Federation
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Arkhangelsk
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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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Ryazan
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Russian Federation
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St. Petersburg
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Russian Federation
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Tver
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Serbia
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Belgrade
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Serbia
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Kragujevac
Country [142] 0 0
Serbia
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Sremska Kamenica
Country [143] 0 0
Singapore
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Singapore
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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South Africa
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Saxonwold, Johannesburg
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Spain
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Barcelona
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Spain
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Castellon
Country [151] 0 0
Spain
State/province [151] 0 0
Cordoba
Country [152] 0 0
Spain
State/province [152] 0 0
La Coruna
Country [153] 0 0
Spain
State/province [153] 0 0
Madrid
Country [154] 0 0
Spain
State/province [154] 0 0
Santa Cruz de Tenerife
Country [155] 0 0
Taiwan
State/province [155] 0 0
Changhua
Country [156] 0 0
Taiwan
State/province [156] 0 0
Kaohsiung Hsien
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taipei City
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
State/province [159] 0 0
Izmir
Country [160] 0 0
Ukraine
State/province [160] 0 0
Chernivtsi
Country [161] 0 0
Ukraine
State/province [161] 0 0
Dnipropetrovsk
Country [162] 0 0
Ukraine
State/province [162] 0 0
Kharkiv
Country [163] 0 0
Ukraine
State/province [163] 0 0
Khmelnytskyi
Country [164] 0 0
Ukraine
State/province [164] 0 0
Lyutizh
Country [165] 0 0
Ukraine
State/province [165] 0 0
Sumy
Country [166] 0 0
Ukraine
State/province [166] 0 0
Uzhgorod
Country [167] 0 0
Ukraine
State/province [167] 0 0
Vinnitsia
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Essex
Country [169] 0 0
United Kingdom
State/province [169] 0 0
West Midlands
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Huddersfield
Country [171] 0 0
United Kingdom
State/province [171] 0 0
London
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Maidstone
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Manchester
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Nottingham
Country [175] 0 0
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State/province [175] 0 0
Peterborough
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A study to compare the safety and efficacy of an aromatase inhibitor in combination with
lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+
metastatic breast cancer (MBC).
Trial website
https://clinicaltrials.gov/show/NCT01160211
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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