The trial is taking place at:
S

Summit Cancer Care | Sutlive Street, Savannah, GA

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Roll-over Study to Allow Continued Access to Ribociclib

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Novartis

Status and phase

Enrolling
Phase 4

Conditions

Metastatic Breast Cancer

Treatments

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

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:

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

Key exclusion Criteria:

  • Permanent discontinuation of ribociclib in the parent study
  • 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)

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

Trial contacts and locations

53

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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