Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01958021
Registration number
NCT01958021
Ethics application status
Date submitted
4/10/2013
Date registered
8/10/2013
Titles & IDs
Public title
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Query!
Scientific title
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Query!
Secondary ID [1]
0
0
2013-003084-61
Query!
Secondary ID [2]
0
0
CLEE011A2301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MONALEESA-2
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced, Metastatic Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - LEE011
Treatment: Drugs - Letrozole
Treatment: Drugs - LEE011 Placebo
Experimental: LEE011 + letrozole - LEE011 (Ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
Placebo comparator: Placebo + letrozole - Matching ribociclib placebo was the control drug and was administered orally once daily.
Treatment: Drugs: LEE011
Ribociclib was administered orally at a dose of 600 mg once daily (three 200 mg capsules).
Treatment: Drugs: Letrozole
Letrozole 2.5 mg tablets taken orally.
Treatment: Drugs: LEE011 Placebo
Matching ribociclib placebo was the control drug and was administered orally once daily.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS) Per Investigator Assessment
Query!
Assessment method [1]
0
0
PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1
Query!
Timepoint [1]
0
0
Up to approximately 20 months
Query!
Secondary outcome [1]
0
0
Overall Response Rate (ORR) as Per Investigator Assessment
Query!
Assessment method [1]
0
0
Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Query!
Timepoint [1]
0
0
Up to approximately 20 months
Query!
Secondary outcome [2]
0
0
Overall Survival (OS)
Query!
Assessment method [2]
0
0
Time from date of randomization to the date of death from any cause.
Query!
Timepoint [2]
0
0
Up to approximately 65 months
Query!
Secondary outcome [3]
0
0
Clinical Benefit Rate (CBR)
Query!
Assessment method [3]
0
0
Clinical Benefit Rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.
Query!
Timepoint [3]
0
0
Up to approximately 20 months
Query!
Secondary outcome [4]
0
0
Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score
Query!
Assessment method [4]
0
0
Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.
Query!
Timepoint [4]
0
0
Up to approximately 20.5 months
Query!
Secondary outcome [5]
0
0
Safety and Tolerability of LEE011
Query!
Assessment method [5]
0
0
Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.
Query!
Timepoint [5]
0
0
Up to approximately 21 months
Query!
Secondary outcome [6]
0
0
Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30
Query!
Assessment method [6]
0
0
The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.
Query!
Timepoint [6]
0
0
Up to approximately 20 months
Query!
Secondary outcome [7]
0
0
QTc Interval
Query!
Assessment method [7]
0
0
Time between the start of the Q wave and the end of the T wave corrected for heart rate
Query!
Timepoint [7]
0
0
Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1
Query!
Eligibility
Key inclusion criteria
1. Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
2. Patient is postmenopausal. Postmenopausal status is defined either by:
* Prior bilateral oophorectomy
* Age =60
* Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial.
3. No prior systemic anti-cancer therapy for advanced disease.
4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
6. Patient must have either:
• Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented).
OR
• If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (Patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation).
7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Patient who received any CDK4/6 inhibitor.
2. Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
Note:
* Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization.
* Patients who received = 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible.
* Any prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 half-lives or 7 days, whichever is longer, before randomization
3. Patient is concurrently using other anti-cancer therapy.
4. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
5. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
* History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
* History of documented congestive heart failure (New York Heart Association functional classification III-IV)
* Documented cardiomyopathy
* Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
* History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
* On screening, any of the following cardiac parameters:
bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
* Systolic blood pressure >160 or <90 mmHg
6. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior start if the treatment:
* That are known strong inducers or inhibitors of CYP3A4.
* That have a known risk to prolong the QT interval or induce Torsades de Pointes.
* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
* Herbal preparations/medications
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/12/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/03/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
668
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Kurralta Park
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - East Melbourne
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [2]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Hawaii
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Dakota
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Washington
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Wisconsin
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Tucuman
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Cordoba
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
La Rioja
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Salzburg
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Vienna
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Wien
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Oost Vlaanderen
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Hasselt
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Leuven
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Namur
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Wilrijk
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
SP
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
British Columbia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Nova Scotia
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Ontario
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Quebec
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Czech Republic
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
CZE
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Aarhus
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Copenhagen
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Odense C
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Vejle
Query!
Country [51]
0
0
Finland
Query!
State/province [51]
0
0
Helsinki
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Turku
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Alpes Maritimes
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Villejuif
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Angers Cedex 02
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Avignon Cedex
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Besancon Cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Bordeaux Cedex
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Creteil
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Le Mans Cedex
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Lyon Cedex
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Pierre Benite Cedex
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Rouen Cedex 1
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Saint-Herblain Cédex
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
North Rhine-westphalia
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Aschaffenburg
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Berlin
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Bielefeld
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Bonn
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Bottrop
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Duesseldorf
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Erlangen
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Essen
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Freiburg
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Fuerth
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Goslar
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Heidelberg
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Muenchen
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Offenbach
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Ravensburg
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Tübingen
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Ulm
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Velbert
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Budapest
Query!
Country [85]
0
0
Hungary
Query!
State/province [85]
0
0
Debrecen
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Gyor
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Gyula
Query!
Country [88]
0
0
Ireland
Query!
State/province [88]
0
0
Cork
Query!
Country [89]
0
0
Ireland
Query!
State/province [89]
0
0
Dublin 4
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Petach Tikva
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Ramat Gan
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Tel Aviv
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
BS
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
GE
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
LC
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
MC
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
ME
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
MI
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
PD
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
PG
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
PI
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
PN
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
RC
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
RM
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
TO
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
TR
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
VT
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
Napoli
Query!
Country [109]
0
0
Korea, Republic of
Query!
State/province [109]
0
0
Gyeonggi Do
Query!
Country [110]
0
0
Korea, Republic of
Query!
State/province [110]
0
0
Korea
Query!
Country [111]
0
0
Korea, Republic of
Query!
State/province [111]
0
0
Seoul
Query!
Country [112]
0
0
Lebanon
Query!
State/province [112]
0
0
Ashrafieh
Query!
Country [113]
0
0
Lebanon
Query!
State/province [113]
0
0
Beirut
Query!
Country [114]
0
0
Lebanon
Query!
State/province [114]
0
0
Saida
Query!
Country [115]
0
0
Netherlands
Query!
State/province [115]
0
0
AZ
Query!
Country [116]
0
0
Netherlands
Query!
State/province [116]
0
0
Alkmaar
Query!
Country [117]
0
0
Netherlands
Query!
State/province [117]
0
0
Amsterdam
Query!
Country [118]
0
0
Netherlands
Query!
State/province [118]
0
0
Deventer
Query!
Country [119]
0
0
Netherlands
Query!
State/province [119]
0
0
Groningen
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Leiden
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Sittard-Geleen
Query!
Country [122]
0
0
Netherlands
Query!
State/province [122]
0
0
Tilburg
Query!
Country [123]
0
0
Netherlands
Query!
State/province [123]
0
0
Zwolle
Query!
Country [124]
0
0
Norway
Query!
State/province [124]
0
0
Bergen
Query!
Country [125]
0
0
Norway
Query!
State/province [125]
0
0
Oslo
Query!
Country [126]
0
0
Russian Federation
Query!
State/province [126]
0
0
Arkhangelsk
Query!
Country [127]
0
0
Russian Federation
Query!
State/province [127]
0
0
Nizhniy Novgorod
Query!
Country [128]
0
0
Russian Federation
Query!
State/province [128]
0
0
Ryazan
Query!
Country [129]
0
0
Singapore
Query!
State/province [129]
0
0
Singapore
Query!
Country [130]
0
0
South Africa
Query!
State/province [130]
0
0
Gauteng
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Andalucia
Query!
Country [132]
0
0
Spain
Query!
State/province [132]
0
0
Cataluna
Query!
Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Catalunya
Query!
Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Comunidad Valenciana
Query!
Country [135]
0
0
Spain
Query!
State/province [135]
0
0
Galicia
Query!
Country [136]
0
0
Spain
Query!
State/province [136]
0
0
Santa Cruz De Tenerife
Query!
Country [137]
0
0
Spain
Query!
State/province [137]
0
0
Madrid
Query!
Country [138]
0
0
Sweden
Query!
State/province [138]
0
0
Eskilstuna
Query!
Country [139]
0
0
Sweden
Query!
State/province [139]
0
0
Goteborg
Query!
Country [140]
0
0
Sweden
Query!
State/province [140]
0
0
Joenkoeping
Query!
Country [141]
0
0
Sweden
Query!
State/province [141]
0
0
Lund
Query!
Country [142]
0
0
Sweden
Query!
State/province [142]
0
0
Uppsala
Query!
Country [143]
0
0
Sweden
Query!
State/province [143]
0
0
Vaxjo
Query!
Country [144]
0
0
Taiwan
Query!
State/province [144]
0
0
Taoyuan Taiwan ROC
Query!
Country [145]
0
0
Taiwan
Query!
State/province [145]
0
0
TWN
Query!
Country [146]
0
0
Taiwan
Query!
State/province [146]
0
0
Kaohsiung
Query!
Country [147]
0
0
Taiwan
Query!
State/province [147]
0
0
Taipei
Query!
Country [148]
0
0
Thailand
Query!
State/province [148]
0
0
Bangkok
Query!
Country [149]
0
0
Turkey
Query!
State/province [149]
0
0
Ankara
Query!
Country [150]
0
0
Turkey
Query!
State/province [150]
0
0
Diyarbakir
Query!
Country [151]
0
0
Turkey
Query!
State/province [151]
0
0
Istanbul
Query!
Country [152]
0
0
Turkey
Query!
State/province [152]
0
0
Izmir
Query!
Country [153]
0
0
United Kingdom
Query!
State/province [153]
0
0
Cornwall
Query!
Country [154]
0
0
United Kingdom
Query!
State/province [154]
0
0
Newcastle upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01958021
Query!
Trial related presentations / publications
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, Andre F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022 Mar 10;386(10):942-950. doi: 10.1056/NEJMoa2114663. Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22. Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum In: J Clin Oncol. 2021 Nov 1;39(31):3525. doi: 10.1200/JCO.21.02277. J Clin Oncol. 2023 Apr 20;41(12):2299-2301. doi: 10.1200/JCO.23.00175. Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15. Hortobagyi GN. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018 Oct 19;20(1):123. doi: 10.1186/s13058-018-1050-7. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155. Erratum In: Ann Oncol. 2019 Nov 1;30(11):1842. doi: 10.1093/annonc/mdz215. Janni W, Alba E, Bachelot T, Diab S, Gil-Gil M, Beck TJ, Ryvo L, Lopez R, Tsai M, Esteva FJ, Aunon PZ, Kral Z, Ward P, Richards P, Pluard TJ, Sutradhar S, Miller M, Campone M. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Jun;169(3):469-479. doi: 10.1007/s10549-017-4658-x. Epub 2018 Feb 5. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, Andre F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. doi: 10.1056/NEJMoa1609709. Epub 2016 Oct 7. Erratum In: N Engl J Med. 2018 Dec 27;379(26):2582. doi: 10.1056/NEJMx180043.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://www.clinicalstudydatarequest.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01958021