Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
Condition: Advanced Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ribociclib; letrozole; goserelin
Intervention description: All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.; All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.; Premenopausal patients additionally received goserelin 3.6mg as monthly implant
Intervention MeSH terms: Letrozole; Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 502.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ribociclib; LEE011; RIBECCA; breast cancer; breast carcinoma; HR-positive; HER2-negative; advanced breast cancer; Letrozole; CDK4/6; breast lump; HER2 positive; metastatic breast cancer; breast cancer positive for human epidermal growth factor receptor 2 (HER2) HER2 positive metastatic breast cancer; breast cancer progression; estrogen-receptor (ER) positive(+) breast cancer; Paget's disease

Summary:

      This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and
      safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+,
      HER2-negative advanced (recurrent or metastatic) breast cancer. Patients were treated with
      daily doses of 600 mg ribociclib (3-weeks-on/1-week-off schedule) in combination with 2.5 mg
      letrozole daily (continuous dosing). Dose adjustments (dose reduction or interruption)
      according to safety findings were allowed.
    

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

          -  Women and men 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