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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/NCT03701334




Registration number
NCT03701334
Ethics application status
Date submitted
21/09/2018
Date registered
10/10/2018
Date last updated
3/10/2023

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
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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 - Liverpool
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Novartis Investigative Site - St Leonards
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Novartis Investigative Site - Auchenflower
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Novartis Investigative Site - Birtinya
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Novartis Investigative Site - Wooloongabba
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Novartis Investigative Site - Bendigo
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Novartis Investigative Site - East Melbourne
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Novartis Investigative Site - Epping
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Novartis Investigative Site - Fitzroy
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Novartis Investigative Site - Franston
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Novartis Investigative Site - Heidelberg
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Novartis Investigative Site - Melbourne
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Novartis Investigative Site - Shepparton
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Novartis Investigative Site - Murdoch
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Novartis Investigative Site - Nedlands
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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2170 - Liverpool
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2109 - North Ryde
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2065 - St Leonards
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2076 - Wahroonga
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2145 - Westmead
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4066 - Auchenflower
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4575 - Birtinya
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4102 - Wooloongabba
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5042 - 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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Ulsan
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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
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of
ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early
Breast Cancer (EBC)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03701334
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03701334