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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02278120
Ethics application status
Date submitted
22/10/2014
Date registered
29/10/2014

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 - Ribociclib
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Letrozole
Treatment: Drugs - Anastrozole
Treatment: Drugs - Goserelin
Treatment: Drugs - Placebo

Experimental: Ribociclib + NSAI/tamoxifen + goserelin - Ribociclib 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: Placebo + NSAI/tamoxifen + goserelin - Placebo 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).

Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin.


Treatment: Drugs: Ribociclib
Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.

Treatment: Drugs: Tamoxifen
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)

Treatment: Drugs: Letrozole
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)

Treatment: Drugs: Anastrozole
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)

Treatment: Drugs: Goserelin
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle

Treatment: Drugs: Placebo
Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) by Investigator Assessment
Timepoint [1] 0 0
From randomization to first documented progression or death, assessed up to approximately 29 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to death, assessed up to approximately 45 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) by Investigator Assessment
Timepoint [2] 0 0
Up to approximately 29 months
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) by Investigator Assessment
Timepoint [3] 0 0
Up to approximately 29 months
Secondary outcome [4] 0 0
Time to Response (TTR) by Investigator Assessment
Timepoint [4] 0 0
Up to approximately 29 months
Secondary outcome [5] 0 0
Duration of Response (DOR) by Investigator Assessment
Timepoint [5] 0 0
Up to approximately 29 months
Secondary outcome [6] 0 0
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score
Timepoint [6] 0 0
Baseline, up to approximately 29 months
Secondary outcome [7] 0 0
Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [7] 0 0
Up to approximately 29 months
Secondary outcome [8] 0 0
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Timepoint [8] 0 0
Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days

Eligibility
Key inclusion criteria
Key inclusion criteria:

* Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
* Patients were premenopausal or perimenopausal at the time of study entry
* Patients who had received (neo) adjuvant therapy for breast cancer were eligible
* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
* Patients had HER2-negative breast cancer
* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion
* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients had adequate bone marrow and organ function

Key exclusion criteria:

* Patients who had received a prior CDK4/6 inhibitor
* Patients were postmenopausal
* Patients who currently had inflammatory breast cancer at screening.
* Patients who had 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.
* Patients had 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.
* Patients with CNS metastases.
* Patients had active cardiac disease or a history of cardiac dysfunction
* Patients were currently using other antineoplastic agents
* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.
Minimum age
18 Years
Maximum age
59 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2023
Sample size
Target
Accrual to date
Final
672
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
Country [1] 0 0
United States of America
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California
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Colorado
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Connecticut
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Florida
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Hawaii
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Illinois
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Kentucky
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Maryland
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Massachusetts
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Michigan
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North Carolina
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Utah
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Cordoba
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La Rioja
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Bruxelles
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Leuven
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Wilrijk
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Leipzig
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Offenbach
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Ulm
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Debrecen
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Szeged
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Szolnok
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Maharashtra
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India
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West Bengal
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Mumbai
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CR
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CT
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LU
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MC
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PG
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PO
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PV
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RM
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TO
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TR
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Italy
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UD
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Napoli
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Gyeonggi Do
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Korea
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Johor
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Konin
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Lisboa
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Porto
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Russian Federation
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Arkhangelsk
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Russian Federation
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Saint Petersburg
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Riyadh
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Singapore
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Alicante
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Andalucia
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Barcelona
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Catalunya
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Islas Baleares
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Madrid
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Pais Vasco
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Spain
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Vizcaya
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Switzerland
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Geneve
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Turkey
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TUR
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Turkey
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Adana
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Turkey
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Ankara
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Diyarbakir
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Edirne
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Turkey
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Izmir
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United Arab Emirates
State/province [139] 0 0
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
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02278120