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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03701334




Registration number
NCT03701334
Ethics application status
Date submitted
21/09/2018
Date registered
10/10/2018

Titles & IDs
Public title
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
Scientific title
A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)
Secondary ID [1] 0 0
2018-002998-21
Secondary ID [2] 0 0
CLEE011O12301C
Universal Trial Number (UTN)
Trial acronym
NATALEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early 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 - Ribociclib
Other interventions - Endocrine Therapy

Experimental: Ribociclib + Endocrine Therapy - Participants will receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously

Active comparator: Endocrine Therapy - Participants will receive endocrine therapy only once daily continuously


Treatment: Drugs: Ribociclib
Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

Other interventions: Endocrine Therapy
ET will be administered according to the local clinical guidelines and current local prescribing information
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (iDFS)
Timepoint [1] 0 0
Up to approximately 91 months
Secondary outcome [1] 0 0
Recurrence-free survival (RFS)
Timepoint [1] 0 0
Up to approximately 91 months
Secondary outcome [2] 0 0
Distant disease-free survival (DDFS)
Timepoint [2] 0 0
Up to approximately 91 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 91 months
Secondary outcome [4] 0 0
Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30
Timepoint [4] 0 0
Up to approximately 91 months
Secondary outcome [5] 0 0
Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30
Timepoint [5] 0 0
Up to approximately 91 months
Secondary outcome [6] 0 0
PK parameters: Ctrough and other applicable parameters for ribociclib
Timepoint [6] 0 0
Cycle 1 Day 15

Eligibility
Key inclusion criteria
* Patient is = 18 years-old at the time of PICF signature
* Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.
* Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
* Patient has breast cancer that is positive for ER and/or PgR
* Patient has HER2-negative breast cancer
* Patient has available archival tumor tissue from the surgical specimen
* Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: anatomic stage group II or III
* If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
* If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has received any CDK4/6 inhibitor
* Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy.
* Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
* Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
* Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
* Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
* Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
* Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
* Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization
* Patient has known HIV infection, Hepatitis B or C infection
* Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
* Patient is currently receiving any of the following substances within 7 days before randomization - Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
* is currently receiving or has received systemic corticosteroids = 2 weeks prior to starting trial treatment
* Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
* Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
* Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial.
* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial

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
7/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
Accrual to date
Final
5101
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Campbelltown
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Novartis Investigative Site - Coffs Harbour
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Novartis Investigative Site - Darlinghurst
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Novartis Investigative Site - Kingswood
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Novartis Investigative Site - Westmead
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Novartis Investigative Site - Birtinya
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Novartis Investigative Site - Liverpool
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
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2450 - Coffs Harbour
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2010 - Darlinghurst
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2747 - Kingswood
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2217 - Kogarah
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2109 - North Ryde
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5041 - Bedford Park
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3550 - Bendigo
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3002 - East Melbourne
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3076 - Epping
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3065 - Fitzroy
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3199 - Franston
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3084 - Heidelberg
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3000 - Melbourne
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3630 - Shepparton
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6150 - Murdoch
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6009 - Nedlands
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2170 - Liverpool
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Grudziadz
Country [184] 0 0
Poland
State/province [184] 0 0
Krakow
Country [185] 0 0
Poland
State/province [185] 0 0
Lodz
Country [186] 0 0
Poland
State/province [186] 0 0
Lublin
Country [187] 0 0
Poland
State/province [187] 0 0
Opole
Country [188] 0 0
Poland
State/province [188] 0 0
Ostroleka
Country [189] 0 0
Poland
State/province [189] 0 0
Otwock
Country [190] 0 0
Poland
State/province [190] 0 0
Wieliszew
Country [191] 0 0
Poland
State/province [191] 0 0
Wroclaw
Country [192] 0 0
Romania
State/province [192] 0 0
Dolj
Country [193] 0 0
Romania
State/province [193] 0 0
Bucuresti
Country [194] 0 0
Romania
State/province [194] 0 0
Cluj-Napoca
Country [195] 0 0
Romania
State/province [195] 0 0
Timisoara
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Saint Petersburg
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Chelyabinsk
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Kazan
Country [199] 0 0
Russian Federation
State/province [199] 0 0
Kostroma
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Krasnoyarsk
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Moscow
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Nizhniy Novgorod
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Novosibirsk
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Obninsk
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Russian Federation
State/province [205] 0 0
Omsk
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Orenburg
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Rostov na Donu
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Ryazan
Country [209] 0 0
Russian Federation
State/province [209] 0 0
St Petersburg
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Tyumen
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Ufa
Country [212] 0 0
Russian Federation
State/province [212] 0 0
Yaroslavl
Country [213] 0 0
Spain
State/province [213] 0 0
Alicante
Country [214] 0 0
Spain
State/province [214] 0 0
Andalucia
Country [215] 0 0
Spain
State/province [215] 0 0
Barcelona
Country [216] 0 0
Spain
State/province [216] 0 0
Castilla Y Leon
Country [217] 0 0
Spain
State/province [217] 0 0
Catalunya
Country [218] 0 0
Spain
State/province [218] 0 0
Comunidad Valenciana
Country [219] 0 0
Spain
State/province [219] 0 0
Extremadura
Country [220] 0 0
Spain
State/province [220] 0 0
Galicia
Country [221] 0 0
Spain
State/province [221] 0 0
Madrid
Country [222] 0 0
Spain
State/province [222] 0 0
Murcia
Country [223] 0 0
Spain
State/province [223] 0 0
Navarra
Country [224] 0 0
Spain
State/province [224] 0 0
Pais Vasco
Country [225] 0 0
Spain
State/province [225] 0 0
Pontevedra
Country [226] 0 0
Spain
State/province [226] 0 0
Santa Cruz De Tenerife
Country [227] 0 0
Spain
State/province [227] 0 0
Burgos
Country [228] 0 0
Spain
State/province [228] 0 0
Girona
Country [229] 0 0
Spain
State/province [229] 0 0
Granada
Country [230] 0 0
Spain
State/province [230] 0 0
Las Palmas de Gran Canaria
Country [231] 0 0
Spain
State/province [231] 0 0
Zaragoza
Country [232] 0 0
Taiwan
State/province [232] 0 0
Changhua
Country [233] 0 0
Taiwan
State/province [233] 0 0
Taichung
Country [234] 0 0
Taiwan
State/province [234] 0 0
Tainan
Country [235] 0 0
Taiwan
State/province [235] 0 0
Taipei
Country [236] 0 0
Taiwan
State/province [236] 0 0
Taoyuan
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Cornwall
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Surrey
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Cardiff
Country [240] 0 0
United Kingdom
State/province [240] 0 0
London
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Nottingham
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Oxford
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Preston
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Translational Research in Oncology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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 not provided in https://clinicaltrials.gov/study/NCT03701334