本研究旨在评估 ribociclib（LEE011）联合其他药物的长期安全性，并为目前正在一项已达到主要目标的 Novartis 资助全球研究中接受 ribociclib 联合其他药物治疗且持续获得临床获益的参与者，提供试验后用药（PTA）。
适应症：Metastatic Breast Cancer
入组条件
纳入标准
- Signed informed consent must be obtained prior to participation in the study.
- Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs and the parent study has fulfilled its primary objective(s).
- Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
- Participant must have evidence of clinical benefit as determined by the Investigator.
排除标准
- Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
- Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
- Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility 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:
- Total abstinence
- Female sterilization
- Male partner sterilization
- Placement of an intrauterine device (IUD)
- Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。