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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02278120




Registration number
NCT02278120
Ethics application status
Date submitted
22/10/2014
Date registered
29/10/2014
Date last updated
6/08/2020

Titles & IDs
Public title
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Scientific title
A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Secondary ID [1] 0 0
2014-001931-36
Secondary ID [2] 0 0
CLEE011E2301
Universal Trial Number (UTN)
Trial acronym
MONALEESA-7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Metastatic 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 - LEE011
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Letrozole
Treatment: Drugs - Anastrozole
Treatment: Drugs - Goserelin
Treatment: Drugs - LEE011 Placebo

Experimental: Ribociclib (LEE011) + NSAI/tamoxifen + goserelin - LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)

Placebo Comparator: LEE011 placebo+NSAI/tamoxifen+goserelin - LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)


Treatment: Drugs: LEE011
LEE011 600 mg daily oral

Treatment: Drugs: Tamoxifen
tamoxifen 20 mg daily oral

Treatment: Drugs: Letrozole
letrozole 2.5 mg daily oral

Treatment: Drugs: Anastrozole
anastrozole 1 mg daily oral

Treatment: Drugs: Goserelin
Goserelin 3.6 mg subcutaneous injection

Treatment: Drugs: LEE011 Placebo
LEE011 placebo 600 mg daily oral

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

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Per Investigator's Assessment - PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause and assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1]. PFS was assessed via a local radiology assessment according to RECIST 1.1
Timepoint [1] 0 0
Up to approximatley 25 months
Secondary outcome [1] 0 0
Overall Survival (OS) - Time from date of randomization to the date of death from any cause
Timepoint [1] 0 0
Up to approximately 69 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) Per Local Assessment - ORR is the percentage of participants 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.
Timepoint [2] 0 0
Up to approximately 25 months
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) - Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.
Timepoint [3] 0 0
Up to approximately 25 months
Secondary outcome [4] 0 0
Safety and Tolerability of LEE011 - Safety and tolerability will be determined by type, frequency and severity of adverse events and laboratory abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Timepoint [4] 0 0
Up to approximately 26 months
Secondary outcome [5] 0 0
Time to Response (TTR) Per Local Investigator's Assessment - Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1. All patients will be included in time to response calculations. Patients who do not achieve a confirmed response will be censored at the maximum follow-up time (i.e. first patient first visit to last patient last visit used for the analysis) for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise.
Timepoint [5] 0 0
Up to approximately 25 months
Secondary outcome [6] 0 0
Duration of Response (DOR) Per Investigator's Assessment - Patients With Confirmed Complete Response (CR) or Partial Response (PR) - Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer
Timepoint [6] 0 0
Up to approximately 25 months
Secondary outcome [7] 0 0
Time to Definitive Deterioration of the ECOG PS From Baseline - Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Timepoint [7] 0 0
Baseline, up to approximately 25 months
Secondary outcome [8] 0 0
Time to 10% Deterioration in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 - Patient reported outcomes for health related quality of life
Timepoint [8] 0 0
Up to approximately 25 months
Secondary outcome [9] 0 0
Change From Baseline in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 - Patient reported outcomes for health related quality of life
Timepoint [9] 0 0
Up to approximately 25 months

Eligibility
Key inclusion criteria
- Patient has advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy

- Patient is premenopausal or perimenopausal at the time of study entry

- Patients who received (neo) adjuvant therapy for breast cancer are eligible

- Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer

- Patient has HER2-negative breast cancer

- Patient must have either measurable disease or If no measurable disease is present,
then at least one predominantly lytic bone lesion

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Patient has adequate bone marrow and organ function
Minimum age
18 Years
Maximum age
59 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient who has received a prior CDK4/6 inhibitor

- Patient is postmenopausal

- Patients who currently have inflammatory breast cancer at screening.

- Patients who received any prior hormonal anti-cancer therapy for advanced breast
cancer, except for = 14 days of tamoxifen or NSAI ± goserelin for advanced breast
cancer prior to randomization.

- Patient has a concurrent malignancy or malignancy within 3 years of randomization,
with the exception of adequately treated basal cell skin carcinoma, squamous cell skin
carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.

- Patient with CNS metastases.

- Patient has active cardiac disease or a history of cardiac dysfunction

- Patient is currently using other antineoplastic agents

- Patient is pregnant or nursing or physiologically capable of becoming pregnant and not
using highly effective contraception

Other protocol-defined Inclusion/Exclusion may apply.

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
Blinded (masking used)
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
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)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Waratah
Recruitment hospital [2] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [3] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [4] 0 0
Novartis Investigative Site - Murdoch
Recruitment hospital [5] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Al Ain Abu Dhabi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-center, randomized, double-blinded, placebo controlled trial in
pre-menopausal women with advanced breast cancer.

The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by
progression free survival (PFS), in premenopausal women with HR positive, HER2 negative
advanced breast cancer
Trial website
https://clinicaltrials.gov/show/NCT02278120
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