Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT02422615
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. MONALEESA-3
• Scientific title: A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
• Date of first enrolment: June 9, 2015
• Target sample size: 726
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02422615
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Czechia, Denmark, France, Germany, Hungary, India, Italy, Jordan, Korea, Republic of, Lebanon, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient is an adult male/female = 18 years old at the time of informed consent and has
signed informed consent before any trial related activities and according to local
guidelines. Female patients must be postmenopausal.

2. Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer by
local laboratory and has HER2-negative breast cancer.

3. Patient must have either measurable disease by RECIST 1.1 or at least one
predominantly lytic bone lesion.

4. Patient has advanced (loco regionally recurrent not amenable to curative therapy, e.g.
surgery and/or radiotherapy, or metastatic) breast cancer.

Patients may be:

- newly diagnosed advanced/metastatic breast cancer, treatment naïve

- relapsed with documented evidence of relapse more than 12 months from completion
of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic
disease

- relapsed with documented evidence of relapse on or within 12 months from
completion of (neo)adjuvant endocrine therapy with no treatment for
advanced/metastatic disease

- relapsed with documented evidence of relapse more than 12 months from completion
of adjuvant endocrine therapy and then subsequently progressed with documented
evidence of progression after one line of endocrine therapy (with either an
antiestrogen or an aromatase inhibitor) for advanced/metastatic disease

- newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed
with documented evidence of progression after one line of endocrine therapy (with
either an antiestrogen or an aromatase inhibitor)

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

6. Patient has adequate bone marrow and organ function

Exclusion Criteria:

1. Patient with symptomatic visceral disease or any disease burden that makes the patient
ineligible for endocrine therapy per the investigator's best judgment.

2. Patient has received prior treatment with chemotherapy (except for neoadjuvant/
adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.

3. Patient with inflammatory breast cancer at screening .

4. Patient with CNS involvement unless they are at least 4 weeks from prior therapy
completion to starting the study treatment and have stable CNS tumor at the time of
screening and not receiving steroids and/or enzyme inducing anti-epileptic medications
for brain metastases

5. Clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality

6. Patient is currently receiving any of the following substances and cannot be
discontinued 7 days prior to start the treatment:

- Known strong inducers or inhibitors of CYP3A4/5,

- That have a known risk to prolong the QT interval or induce Torsades de Pointes.

- Those have a narrow therapeutic window and are predominantly metabolized through
CYP3A4/5.

- Herbal preparations/medications, dietary supplements.

Other Protocol-defined Inclusion/Exclusion may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Breast Cancer

Intervention(s)

Drug: Ribociclib

Drug: Ribociclib placebo

Drug: fulvestrant

Primary Outcome(s)

Progression Free Survival (PFS) Per Investigator Assessment [Time Frame: Up to approximately 26 months]

Secondary Outcome(s)

Change From Baseline in the Global Health Status/QoL Scale Score of the EORTC QLQ-C30 [Time Frame: Up to approximately 26 months]

Progression Free Survival (PFS) Per Blinded Independent Review Committee (BICR) [Time Frame: Up to approximately 26 months]

Time to Response (TTR) [Time Frame: Up to approximately 26 months]

Overall Survival (OS) [Time Frame: Up to approximately 58 months]

Safety and Tolerability of LEE011 [Time Frame: Up to approximately 26 months]

Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30 [Time Frame: Up to approximately 26 months]

Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score [Time Frame: Up to approximately 26 months]

Clinical Benefit Rate (CBR) [Time Frame: Up to approximately 26 months]

Duration of Response (DOR) [Time Frame: Up to approximately 26 months]

Overall Response Rate (ORR) [Time Frame: Up to approximately 26 months]

Secondary ID(s)

2015-000617-43

CLEE011F2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02422615