Last updated on April 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Metastatic Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female

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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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