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Trial record 1 of 1 for:    NCT02278120
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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278120
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Results First Posted : February 26, 2019
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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


Condition or disease Intervention/treatment Phase
Advanced Metastatic Breast Cancer Drug: LEE011 Drug: Tamoxifen Drug: Letrozole Drug: Anastrozole Drug: Goserelin Drug: LEE011 Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 20, 2014
Actual Primary Completion Date : August 21, 2017
Estimated Study Completion Date : March 27, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: LEE011
LEE011 600 mg daily oral

Drug: Tamoxifen
tamoxifen 20 mg daily oral

Drug: Letrozole
letrozole 2.5 mg daily oral

Drug: Anastrozole
anastrozole 1 mg daily oral

Drug: Goserelin
Goserelin 3.6 mg subcutaneous injection
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)
 Drug: Tamoxifen
tamoxifen 20 mg daily oral

Drug: Letrozole
letrozole 2.5 mg daily oral

Drug: Anastrozole
anastrozole 1 mg daily oral

Drug: Goserelin
Goserelin 3.6 mg subcutaneous injection

Drug: LEE011 Placebo
LEE011 placebo 600 mg daily oral


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) Per Investigator's Assessment [ Time Frame: Up to approximatley 25 months ]
    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


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 69 months ]
    Time from date of randomization to the date of death from any cause

  2. Overall Response Rate (ORR) Per Local Assessment [ Time Frame: Up to approximately 25 months ]
    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.

  3. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 25 months ]
    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.

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

  5. Time to Response (TTR) Per Local Investigator's Assessment [ Time Frame: Up to approximately 25 months ]
    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.

  6. Duration of Response (DOR) Per Investigator's Assessment - Patients With Confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 25 months ]
    Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer

  7. Time to Definitive Deterioration of the ECOG PS From Baseline [ Time Frame: Baseline, up to approximately 25 months ]
    Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

  8. Time to 10% Deterioration in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 25 months ]
    Patient reported outcomes for health related quality of life

  9. Change From Baseline in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 25 months ]
    Patient reported outcomes for health related quality of life


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278120


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] February 24, 2017
Statistical Analysis Plan  [PDF] September 27, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02278120    
Other Study ID Numbers: CLEE011E2301
2014-001931-36 ( EudraCT Number )
First Posted: October 29, 2014    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LEE011
ribociclib
HR-positive
HER2-negative
Advanced breast cancer
Letrozole
Anastrozole
Tamoxifen
Goserelin
 CDK
CDK4
CDK6
CDK4/6
Phase III
ER-positive
PR-positive
Premenopausal
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Anastrozole
Goserelin
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents