Metastatic Breast Cancer
Conditions
Keywords
Roll-over Protocol, Post Trial Access (PTA), Ribociclib (LEE011), Ribociclib in combination with other drugs, Hormone Receptor (HR), HR-positive, Human Epidermal Growth Factor Receptor 2 (HER2), HER2-negative, Breast Cancer
Brief summary
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).
Detailed description
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.
Interventions
DRUGRibociclib
Participants continue ribociclib as was administered in their parent study
DRUGLetrozole
Participants continue ribociclib in combination with letrozole as was administered in their parent study
DRUGAnastrozole
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
DRUGGoserelin
Participants continue ribociclib in combination with goserelin as was administered in their parent study
DRUGTamoxifen
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
DRUGFulvestrant
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. Key
Exclusion criteria
* 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: 1. Total abstinence 2. Female sterilization 3. Male partner sterilization 4. 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. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events (AES) | From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit rate | Up to 8 years | Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits |
Countries
Argentina, Brazil, China, Costa Rica, Greece, Hong Kong, India, Italy, Japan, Lebanon, Mexico, Peru, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United States, Vietnam
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed