Clinical Trials /

Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

NCT03096847

Description:

A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative advanced or metastatic breast cancer

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
  • Official Title: A National Phase IIIb, Multi-center, Open Label Study for Women and Men With Hormone-receptor Positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Ribociclib (LEE011) in Combination With Letrozole

Clinical Trial IDs

  • ORG STUDY ID: CLEE011XDE01
  • SECONDARY ID: CLEE011XDE01
  • SECONDARY ID: 2016-002556-24
  • NCT ID: NCT03096847

Conditions

  • Advanced Metastatic Breast Cancer

Interventions

DrugSynonymsArms
ribociclibLEE011ribociclib + letrozole
letrozoleribociclib + letrozole
goserelinribociclib + letrozole

Purpose

A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative advanced or metastatic breast cancer

Trial Arms

NameTypeDescriptionInterventions
ribociclib + letrozoleExperimentalAll patients will receive ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally receive goserelin 3.6 mg i.m. monthly
  • ribociclib
  • letrozole
  • goserelin

Eligibility Criteria

        Inclusion Criteria:

          -  Patient is an adult, ≥ 18 years old at the time of informed consent and has signed
             informed consent before any trial related activities and according to local guidelines

          -  Patients with advanced (locoregionally recurrent or metastatic) breast cancer not
             amenable to curative therapy.

          -  Patient has a histologically and/or cytologically confirmed diagnosis of
             estrogen-receptor positive and/or progesterone receptor positive and HER2-negative
             breast cancer by local laboratory. Local pathology is sufficient for assessment.

          -  Patient must have either:

               1. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1
                  criteria ).

               2. Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable
                  disease

               3. Non-measurable disease

          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

        Exclusion Criteria

          -  Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.

          -  Patient has a known hypersensitivity to any of the excipients of ribociclib or
             letrozole

          -  Patients with current inflammatory breast cancer.

          -  Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast
             cancer

          -  Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic
             breast cancer

          -  Patient has central nervous system (CNS) involvement. If patient is fulfilling the
             following 3 criteria she/he is eligible for the trial.

               1. completed prior therapy (including radiation and/or surgery) for CNS metastases ≥
                  28 days prior to the start of study and

               2. CNS tumor is clinically stable at the time of screening and

               3. Patient is not receiving steroids and enzyme inducing anti-epileptic medications
                  for brain metastases

          -  Patient has active cardiac disease or a history of cardiac dysfunction
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical Benefit Rate (CBR) in women and men with hormone receptor positiv, HER-2 negative breast cancer treated with ribocilib and letrozole
Time Frame:At 24 weeks after last patient enrolled in trial
Safety Issue:
Description:Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with Complete Response (CR), Partial response (PR) or Stable disease (SD) lasting 24 weeks or longer as well as patients with NCRNPD >24 for patients with non-measurable disease

Secondary Outcome Measures

Measure:CBR
Time Frame:At 24 weeks
Safety Issue:
Description:To assess the clinical benefit rate (CBR) after 24 weeks among pre-, peri- and postmenopausal women and men without prior therapy for advanced disease
Measure:CBR
Time Frame:At 24 weeks
Safety Issue:
Description:To assess the clinical benefit rate (CBR) after 24 weeks for ribociclib among pre-, peri- and postmenopausal women and men who were pretreated for advanced disease
Measure:Progression free surviival (PFS) for different populations at month 12 and 18 months
Time Frame:At 12 and 18 months At 12 and 24 months up to approximately 80 weeks
Safety Issue:
Description:PFS based on radiologic assessment by investigator using RECIST 1.1 criteria
Measure:Overall Survival (OS)
Time Frame:At 12 and 24 months up to approximately 80 weeks
Safety Issue:
Description:Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.
Measure:Overall response rate (ORR)
Time Frame:At 24 weeks At 12 and 24 months up to approximately 80 weeks
Safety Issue:
Description:Overall response rate (ORR) defined as complete response or partial response as defined by RECIST 1.1
Measure:Patient reported Quality of Life (QoL) via EORTC QLQ-C30
Time Frame:Basline, every cycle (4 weeks) until week 48 (cycle 12), then every 12 weeks up to 80 weeks
Safety Issue:
Description:To evaluate health related quality of life (QoL) via EORTC QLQ-C30. Scoring will follow instructions in manual.
Measure:Patient reported Quality of Life (QoL) via EORTC BR-23
Time Frame:Basline, every cycle (4 weeks) until week 48 (cycle 12), then every 12 weeks up to 80 weeks
Safety Issue:
Description:To evaluate health related quality of life (QoL) via EORTC BR-23. Scoring will follow instructions in manual.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • ribociclib
  • LEE011
  • RIBECCA
  • breast cancer
  • breast carcinoma
  • HR-positive
  • HER2-negative
  • advanced breast cancer
  • Letrozole
  • CDK4/6

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