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Trial record 46 of 190 for:    Oral Cancer | ( Map: Mexico )

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

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ClinicalTrials.gov Identifier: NCT02278120
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Results First Posted : February 26, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE October 29, 2014
Results First Submitted Date  ICMJE August 17, 2018
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE November 20, 2014
Actual Primary Completion Date August 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
Progression Free Survival (PFS) [ 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 RECIST 1.1
Change History Complete list of historical versions of study NCT02278120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Overall Survival (OS) [ Time Frame: Up to approximately 69 months ]
    Time from date of randomization to the date of death from any cause
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
  • Overall Survival (OS) [ Time Frame: Up to approximately 69 months ]
    Time from date of randomization to the date of death from any cause
  • Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 25 months ]
    Proportion of patients with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1
  • Safety and Tolerability of LEE011 determined by type, frequency and severity of adverse events and laboratory abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ 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
  • Time to Response (TTR) [ Time Frame: Up to approximately 25 months ]
    Time from randomization to the first documented and confirmed response (complete response or partial response)
  • Duration of Response (DOR) [ 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
  • 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)
  • 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
  • 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
  • Overall Response Rate (ORR) [ Time Frame: Up to approximately 25 months ]
    Proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Advanced Metastatic Breast Cancer
Intervention  ICMJE
  • 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
  • Drug: LEE011 Placebo
    LEE011 placebo 600 mg daily oral
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: LEE011
    • Drug: Tamoxifen
    • Drug: Letrozole
    • Drug: Anastrozole
    • Drug: Goserelin
  • 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)
    Interventions:
    • Drug: Tamoxifen
    • Drug: Letrozole
    • Drug: Anastrozole
    • Drug: Goserelin
    • Drug: LEE011 Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 7, 2018)
672
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2014)
660
Estimated Study Completion Date  ICMJE December 21, 2020
Actual Primary Completion Date August 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Arab Emirates,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02278120
Other Study ID Numbers  ICMJE CLEE011E2301
2014-001931-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP