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

• Status: Completed
• Trial end date: 2020-02-06
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Goserelin; Hormones; Letrozole

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