臨床研究等提出・公開システム

Date of registration	Jan. 08, 2015
Last modified on	Nov. 25, 2025
Trial ID	jRCT2080222714

Scientific Title	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
Public Title	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

Completion Date or Terminated date	Sept. 08, 2022
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Plan to share IPD	No
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Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name	Hirano Takamitsu
	Contact Name for Scientific Queries	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Phone Number	+81-120-003-293
	E-mail Address	rinshoshiken.toroku2@novartis.com

Contact for Public Queries	Name	Hirano Takamitsu
	Contact Name for Public Queries	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Phone Number	+81-120-003-293
	E-mail Address	rinshoshiken.toroku2@novartis.com

Recruitment Status	completed

Date of First Enrolment		Feb. 04, 2015
Target Sample Size		60
Study Type		Interventional
Study Design	Study Design	This is an open label, multi center, dose escalation, phase Ib study. Patients may continue study treatment until disease progression or until discontinuation of study treatment due to unacceptable toxicities or withdraw their consent. After discontinuation of study treatment, all patients will be followed for safety for 30 days after the last dose of study treatment.
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion 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	-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.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Female
Health Condition or Problem Studied		advanced breast cancer with HR-positive and HER2-negative
Intervention(s)		Dose escalation part: LEE011+Letrozole Dose expantion part: LEE011+Letrozole or LEE011+Fulvestrant oe LEE011+Tamoxifen+Goserelin
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Primary Outcome		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.
Secondary Outcome

Primary Sponsor	Novartis Pharma. K.K.
Secondary Sponsor

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	The Cancer Institute Hospital of JFCR IRB
Address of IRB	3-8-31, Ariake, Koto-ku, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Jan. 07, 2015

Secondary ID No.	NCT02333370
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-152766
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan

History of Changes

No	Publication date
7	Nov. 25, 2025	(this page)	Changes
6	June. 21, 2023	Detail	Changes
5	Nov. 18, 2021	Detail	Changes
4	Aug. 07, 2020	Detail	Changes
3	Feb. 23, 2017	Detail	Changes
2	Aug. 19, 2016	Detail	Changes
1	Jan. 08, 2015	Detail

List of change history