A Phase 4 interventional study of Ribociclib and Letrozole in Metastatic Breast Cancer, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 73 sites in 22 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
This is an open-label, multi-center, roll-over study to evaluate the long-term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.
This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study.
Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 134 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:
Other protocol-defined inclusion/exclusion criteria may apply.
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
Drug: Ribociclib · Drug: Letrozole · Drug: Anastrozole · Drug: Goserelin · Drug: Tamoxifen · Drug: Fulvestrant
Participants continue ribociclib as was administered in their parent study
Also known as: LEE011
Participants continue ribociclib in combination with letrozole as was administered in their parent study
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Participants continue ribociclib in combination with goserelin as was administered in their parent study
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
Percentage of participants with treatment-emergent adverse events (AES)
The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment
Time frame: From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years
Clinical benefit rate
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
Time frame: Up to 8 years
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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