Study of safety and efficacy of ribociclib and letrozole or fulvestrant or tamoxifen in preand postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer

A phase Ib dose escalation study of the combination of ribociclib with letrozole and dose expansion of ribiciclib with hormonal therapy for the treatment of pre-(with goserelin) and postmenopausal women with hormone receptor positive HER2-negative, advanced breast cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222714

Enrollment

Registered

2015-01-08

Start date

2015-02-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced breast cancer with HR-positive and HER2-negative

Interventions

Dose escalation part: LEE011+Letrozole Dose expantion part: LEE011+Letrozole or LEE011+Fulvestrant oe LEE011+Tamoxifen+Goserelin

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -Women with advanced breast cancer not amenable to curative therapy. -HR positive, HER2 negative. -Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. -Patient has adequate bone marrow and organ function.

Exclusion criteria

Exclusion criteria: -Patients with inflammatory breast cancer. -Patient who received any prior systemic anti-cancer therapy for advanced breast cancer. -Patient is currently using other anti-cancer therapy. -Patient has a concurrent malignancy. -Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.

Design outcomes

Primary

Measure	Time frame
Dose escalation: Frequency of DLTs at each dose level associated with administration of ribociclib and letrozole in a 28 day cycle. Dose expansion: Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.	—

Countries

Asia except Japan, Japan

Contacts

Public ContactTakamitsu Hirano

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026