Roll-over Study to Allow Continued Access to Ribociclib

Official record

Identifier

NCT05161195

Recruiting locations

countries

United StatesArgentinaBrazilChinaCosta RicaGreeceHong KongIndiaItalyJapanLebanonMexicoPeruPolandPortugalSingaporeSouth AfricaSouth KoreaSpainTaiwanTurkey (Türkiye)Vietnam

Interventions studied

RibociclibLetrozoleAnastrozoleGoserelinTamoxifenFulvestrant

Lead sponsor

Novartis Pharmaceuticals

Target enrolment

134 participants

Study type

INTERVENTIONAL

Phase

Phase 4

Status

Active, not recruiting

First posted

Dec 17, 2021

Last updated on the registry

Oct 1, 2026

Age

18 Years – 100 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Breast Cancer