Clinical Trials /

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

NCT02278120

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CLEE011E2301
  • NCT ID: NCT02278120

Conditions

  • Advanced, Metastatic Breast Cancer

Interventions

DrugSynonymsArms
LEE011LEE011 + NSAI/tamoxifen + goserelin
TamoxifenLEE011 + NSAI/tamoxifen + goserelin
LetrozoleLEE011 + NSAI/tamoxifen + goserelin
AnastrozoleLEE011 + NSAI/tamoxifen + goserelin
GoserelinLEE011 + NSAI/tamoxifen + goserelin
LEE011 PlaceboLEE011 placebo + NSAI/tamoxifen+ goserelin

Purpose

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

Detailed Description

      The purpose of this study is to assess the efficacy of LEE011, as measured by progression
      free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast
      cancer
    

Trial Arms

NameTypeDescriptionInterventions
LEE011 + NSAI/tamoxifen + goserelinExperimentalLEE011 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)
  • LEE011
  • Tamoxifen
  • Letrozole
  • Anastrozole
  • Goserelin
LEE011 placebo + NSAI/tamoxifen+ goserelinPlacebo ComparatorLEE011 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)
  • Tamoxifen
  • Letrozole
  • Anastrozole
  • Goserelin
  • LEE011 Placebo

Eligibility 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
      
Maximum Eligible Age:59 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Up to approximatley 25 months
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Up to approximately 69 months
Safety Issue:
Description:Time from date of randomization to the date of death from any cause
Measure:Clinical Benefit Rate (CBR)
Time Frame:Up to approximately 25 months
Safety Issue:
Description: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
Measure:Safety and Tolerability of LEE011
Time Frame:Up to approximately 26 months
Safety Issue:
Description: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
Measure:Time to Response (TTR)
Time Frame:Up to approximately 25 months
Safety Issue:
Description:Time from randomization to the first documented and confirmed response (complete response or partial response)
Measure:Duration of Response (DOR)
Time Frame:Up to approximately 25 months
Safety Issue:
Description:Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer
Measure:Time to definitive deterioration of the ECOG PS from baseline
Time Frame:Baseline, up to approximately 25 months
Safety Issue:
Description:Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Measure:Time to 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30
Time Frame:Up to approximately 25 months
Safety Issue:
Description:Patient reported outcomes for health related quality of life
Measure:Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30
Time Frame:Up to approximately 25 months
Safety Issue:
Description:Patient reported outcomes for health related quality of life
Measure:Overall Response Rate (ORR)
Time Frame:Up to approximately 25 months
Safety Issue:
Description:Proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • HR-positive
  • HER2-negative
  • Advanced breast cancer
  • Letrozole
  • Anastrozole
  • Tamoxifen
  • Goserelin
  • CDK
  • CDK4
  • CDK6
  • CDK4/6
  • Phase III
  • ER-positive
  • PR-positive
  • Premenopausal

Last Updated

December 30, 2017