Roll-over study to allow continued access to ribociclib

Recruitment & Eligibility

Status: Without startig enrollment

Sex: Female

Target Recruitment: 0

Inclusion Criteria

1.Signed informed consent must be obtained prior to participation in the study.
2.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).

3.Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
4.Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.

5. Participant must have evidence of| clinical benefit as determined by the Investigator.

Exclusion Criteria

1. 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.

2. Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligbility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).

3. Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).

4. 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:
a.Total abstinence
b.Female sterilization
c.Male partner sterilization
d.Placement of an intrauterine device (IUD)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical benefits and may continue receiving study treatment.<br> NAME OF THE RESULT: Efficacy<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Bi-annual ;Will be monitored y assessing and collecting of adverse events at every visit.<br> NAME OF THE RESULT: Safety<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: At every visit

Secondary Outcome Measures

Name	Time	Method
Clinical benefits and may continue receiving study treatment.<br> NAME OF THE RESULT: Efficacy<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Bi-annual ;Will be monitored y assessing and collecting of adverse events at every visit.<br> NAME OF THE RESULT: Safety<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: At every visit ;To evaluate the clinical benefit from study treatment as assessed by the investigator (per local standard practice)<br> NAME OF THE RESULT: Clinical Benefit<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: At every visit