Roll-over Study to Allow Continued Access to Ribociclib

Novartis

Status and phase: Enrolling; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: Letrozole; Drug: Ribociclib; Drug: Goserelin; Drug: Fulvestrant; Drug: Anastrozole; Drug: Tamoxifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT05161195

CLEE011A2412B

2021-005184-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study

Enrollment: 137 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion Criteria:

1. 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)
2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
3. Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

1. Permanent discontinuation of ribociclib in the parent study
2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Ribociclib

Other group

Description:

All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.

Treatment:

Drug: Tamoxifen

Drug: Fulvestrant

Drug: Anastrozole

Drug: Goserelin

Drug: Ribociclib

Drug: Letrozole