ACTIVE_NOT_RECRUITING

Roll-over Study to Allow Continued Access to Ribociclib

Conditions

Metastatic Breast Cancer 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2022-07-07

Study Completion:2030-08-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05161195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224

United States

Highlands Oncology Group

Fayetteville, Arkansas, 72703

United States

Beverly Hills Cancer Center

Beverly Hills, California, 90211

United States

Poudre Valley Hospital

Fort Collins, Colorado, 80528

United States

Mid Florida Hematology And Onc Ctr

Orange, Florida, 32763

United States

Summit Cancer Care

Savannah, Georgia, 31405

United States

John D Archbold Memorial Hospital

Thomasville, Georgia, 31792

United States

Duly Health and Care

Plainfield, Illinois, 60585

United States

Indian Univ Health Goshen Center forCancer

Goshen, Indiana, 46526

United States

Northern Light Mercy Hospital

Portland, Maine, 04102

United States

Englewood Health

Englewood, New Jersey, 07631

United States

The Valley Hospital-Luckow Pavillion

Paramus, New Jersey, 07652

United States

Eastchester Center for Cancer Care

The Bronx, New York, 10469

United States

University Hospitals of Cleveland Seidman Cancer Center

Cleveland, Ohio, 44106

United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74136

United States

Millennium Research Clin Develop

Houston, Texas, 77090

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-07

Study Completion Date2030-08-14

Study Record Updates

Study Start Date2022-07-07

Study Completion Date2030-08-14

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Metastatic Breast Cancer