A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Continued access to Ribociclib for metastatic breast cancer patients

NCT: NCT05161195 · Status: ACTIVE NOT RECRUITING · Phase: Phase 4 · Sponsor: Novartis Pharmaceuticals · Started: 2022-07-07 · Est. Completion: 2030-08-14

Plain English Summary

Roll-over Study to Allow Continued Access to Ribociclib is a Phase 4 clinical trial sponsored by Novartis Pharmaceuticals studying Metastatic Breast Cancer. This trial offers patients currently benefiting from Ribociclib a way to continue their treatment after their original study ends. It is for patients with metastatic breast cancer who are already taking Ribociclib in a Novartis-sponsored study and are showing clinical benefit. Participation involves continuing the same Ribociclib treatment and attending regular study visits and assessments. The alternative is to stop Ribociclib treatment if they do not join this study, which may mean returning to standard care or other treatment options. The trial aims to enroll 134 participants.

Official 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).

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with metastatic breast cancer who are currently enrolled in a Novartis-sponsored study and receiving Ribociclib. Must have completed at least 6 cycles of Ribociclib in their original study and be showing clinical benefit. Cannot have stopped Ribociclib due to severe side effects or disease progression in the original study. Women of childbearing potential must agree to use effective contraception. This trial is studying Metastatic Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the frequency and severity of side effects that may occur while taking Ribociclib for up to 8 years, ensuring long-term safety is monitored. The specific primary outcome measures are: 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial matters because it provides a crucial pathway for patients to continue a treatment that is working for them, filling a gap in ongoing access to beneficial therapies. This research targets Metastatic Breast Cancer, where improved treatment options are needed.

Investor Insight

This study signals Novartis's commitment to supporting patients on Ribociclib, potentially indicating confidence in its long-term efficacy and safety profile for metastatic breast cancer. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if continuing Ribociclib in this study is the right choice for you, considering your current health and treatment response. Be prepared for regular clinic visits for monitoring and to receive your study medication. Understand that you will continue the same treatment regimen you are already on, with ongoing safety assessments. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility 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/exclusion criteria may apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05161195?

NCT05161195 is a Phase 4 INTERVENTIONAL study titled "Roll-over Study to Allow Continued Access to Ribociclib." It is currently active, not recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 134 participants.

What conditions does NCT05161195 study?

This trial investigates treatments for Metastatic Breast Cancer. The primary condition under study is Metastatic Breast Cancer.

What treatments are being tested in NCT05161195?

The interventions being studied include: Ribociclib (DRUG), Letrozole (DRUG), Anastrozole (DRUG), Goserelin (DRUG), Tamoxifen (DRUG). Participants continue ribociclib as was administered in their parent study

What does Phase 4 mean for NCT05161195?

Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.

What is the current status of NCT05161195?

This trial is currently "Active, Not Recruiting." It started on 2022-07-07. The estimated completion date is 2030-08-14.

Who is sponsoring NCT05161195?

NCT05161195 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05161195?

The trial aims to enroll 134 participants. The trial status is active, not recruiting.

How is NCT05161195 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT05161195?

The primary outcome measures are: 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). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05161195 being conducted?

This trial is being conducted at 20 sites, including Chandler, Arizona; Fayetteville, Arkansas; Beverly Hills, California; Fort Collins, Colorado and 16 more sites (United States, Argentina, Brazil).

Where can I find official information about NCT05161195?

The official record for NCT05161195 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05161195. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05161195 testing in simple terms?

This trial offers patients currently benefiting from Ribociclib a way to continue their treatment after their original study ends. It is for patients with metastatic breast cancer who are already taking Ribociclib in a Novartis-sponsored study and are showing clinical benefit.

Why is this trial significant?

This trial matters because it provides a crucial pathway for patients to continue a treatment that is working for them, filling a gap in ongoing access to beneficial therapies.

What are the potential risks of participating in NCT05161195?

The most common risks include side effects like fatigue, nausea, low blood cell counts, and diarrhea, which are monitored closely. There is a risk of liver problems, heart rhythm changes, and blood clots, though these are less common and require careful monitoring. Stopping treatment due to side effects is a possibility, as with any medication. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05161195?

Ask your doctor if continuing Ribociclib in this study is the right choice for you, considering your current health and treatment response. Be prepared for regular clinic visits for monitoring and to receive your study medication. Understand that you will continue the same treatment regimen you are already on, with ongoing safety assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05161195 signal from an investment perspective?

This study signals Novartis's commitment to supporting patients on Ribociclib, potentially indicating confidence in its long-term efficacy and safety profile for metastatic breast cancer. This is a Phase 4 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves continuing the same Ribociclib treatment and attending regular study visits and assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Metastatic Breast Cancer Trials

View all Metastatic Breast Cancer clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.