Metastatic Breast CancerPhase 4NCT05161195
Roll-over Study to Allow Continued Access to Ribociclib
A Phase 4 study testing Ribociclib, Letrozole and Anastrozole in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 73 sites in 22 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Ribociclib, Letrozole and Anastrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 73 sitesin 22 countries
- Study dates
- 7 Jul 2022to 14 Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
73 sites in 22 countries.
73 sites in 22 countries
United States16 sites
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224
University Hospitals of Cleveland Seidman Cancer Center
Cleveland, Ohio, 44106
Englewood Health
Englewood, New Jersey, 07631
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Poudre Valley Hospital
Fort Collins, Colorado, 80528
Indian Univ Health Goshen Center forCancer
Goshen, Indiana, 46526
Millennium Research Clin Develop
Houston, Texas, 77090
Mid Florida Hematology And Onc Ctr
Orange, Florida, 32763
The Valley Hospital-Luckow Pavillion
Paramus, New Jersey, 07652
Duly Health and Care
Plainfield, Illinois, 60585
Northern Light Mercy Hospital
Portland, Maine, 04102
Summit Cancer Care
Savannah, Georgia, 31405
Eastchester Center for Cancer Care
The Bronx, New York, 10469
John D Archbold Memorial Hospital
Thomasville, Georgia, 31792
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74136
China15 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Changsha, Hunan, 410013
Novartis Investigative Site
Chongqing, Chongqing Municipality, 404100
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Harbin, Heilongjiang, 150081
Novartis Investigative Site
Kunming, Yunnan, 650106
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Qingdao, 266000
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Shijiazhuang, Hebei, 050011
Novartis Investigative Site
Suzhou, Jiangsu, 215004
Novartis Investigative Site
Tianjin, 300480
Brazil7 sites
Novartis Investigative Site
Florianópolis, Santa Catarina, 88020-210
Novartis Investigative Site
Ijuí, Rio Grande do Sul, 98700-000
Novartis Investigative Site
Natal, Rio Grande do Norte, 59075-740
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000
Novartis Investigative Site
São Paulo, São Paulo, 01317-000
Novartis Investigative Site
São Paulo, São Paulo, 03102-002
Novartis Investigative Site
São Paulo, 01255-000
Japan4 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138431
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677
Novartis Investigative Site
Koto Ku, Tokyo, 1358550
Novartis Investigative Site
Osaka, Osaka, 5400006
Turkey (Türkiye)4 sites
Novartis Investigative Site
Diyarbakır, Sur, 21280
Novartis Investigative Site
Izmir, 35100
Novartis Investigative Site
Kecioren Ankara, 06010
Novartis Investigative Site
Malatya, Battalgazi, 44280
Lebanon3 sites
Novartis Investigative Site
Beirut, 1100 2070
Novartis Investigative Site
Beirut, 113-0236
Novartis Investigative Site
El Chouf, LBN, 1503-2010
Portugal3 sites
Novartis Investigative Site
Lisbon, 1400-038
Novartis Investigative Site
Loures, 2674-514
Novartis Investigative Site
Porto, 4200-072
South Africa3 sites
Novartis Investigative Site
Cape Town, 7500
Novartis Investigative Site
Johannesburg, 2196
Novartis Investigative Site
Pretoria, 0002
India2 sites
Novartis Investigative Site
Bhubaneswar, Odisha, 751007
Novartis Investigative Site
Delhi, 110085
Peru2 sites
Novartis Investigative Site
San Borja, Lima region, 15036
Novartis Investigative Site
Trujillo, La Libertad, 13011
South Korea2 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Taiwan2 sites
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
About this study
Official title: A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
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).
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Ribociclib, Letrozole, Anastrozole, Goserelin, Tamoxifen
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
Also called LEE011
Participants continue ribociclib as was administered in their parent study
LetrozoleDrug
Participants continue ribociclib in combination with letrozole as was administered in their parent study
AnastrozoleDrug
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
GoserelinDrug
Participants continue ribociclib in combination with goserelin as was administered in their parent study
TamoxifenDrug
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
FulvestrantDrug
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib | Other | 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). Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole; Drug: Goserelin; Drug: Tamoxifen; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years
Secondary outcomes (1)
Clinical benefit rate
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start7 Jul 2022
- Primary completion28 Jun 2030 (estimated)
- Study completion14 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161195
- Sponsor's protocol ID
- CLEE011A2412B
- Other IDs
- 2024-514891-41-00
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
- ClinicalTrials.gov ID
- NCT05161195
- Acronym / sponsor ID
- CLEE011A2412B
- Conditions
- Metastatic Breast Cancer
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 28 Jun 2030 (estimated)
- Study completion
- 14 Aug 2030 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribociclib | Other | Drug: Ribociclib, Drug: Letrozole, Drug: Anastrozole, Drug: Goserelin, Drug: Tamoxifen, Drug: FulvestrantParticipants 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (10 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibociclibAlso: LEE011Participants continue ribociclib as was administered in their parent study | Drug | Ribociclib |
| LetrozoleParticipants continue ribociclib in combination with letrozole as was administered in their parent study | Drug | Ribociclib |
| AnastrozoleParticipants continue ribociclib in combination with anastrozole as was administered in their parent study | Drug | Ribociclib |
| GoserelinParticipants continue ribociclib in combination with goserelin as was administered in their parent study | Drug | Ribociclib |
| TamoxifenParticipants continue ribociclib in combination with tamoxifen as was administered in their parent study | Drug | Ribociclib |
| FulvestrantAll participants continue ribociclib in combination with fulvestrant as was administered in their parent study | Drug | Ribociclib |
Primary outcome
Percentage of participants with treatment-emergent adverse events (AES)
Time frame: 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
1 secondary outcome
Clinical benefit rate
Time frame: Up to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
73 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ribociclib, Letrozole and Anastrozole in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 73 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, China, Brazil, Japan, Turkey (Türkiye) and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with treatment-emergent adverse events (AES) (time frame: From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.