臨床研究等提出・公開システム

Date of registration	July. 10, 2026
Last modified on	July. 10, 2026
Trial ID	jRCT2031260300

Scientific Title	"An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease" (KANDELA-302)
Public Title	BGB-43395-302

Contact for Scientific Queries	Name	Fukumoto Shigeru
	Affiliation	BeOne Medicines Japan
	Address	Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan
	Telephone	+81-800-919-0351
	E-mail	medinfojp@beonemed.com
Contact for Public Queries	Name	Hamano Fumiaki
	Affiliation	BeOne Medicines Japan
	Address	Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan
	Telephone	+81-800-919-0351
	E-mail	MedInfoJP@beigene.com

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 21, 2026
Actual date of first enrollment		June. 15, 2026
Target sample size		85
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent. -Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer. -Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1. -Adequate organ function.
	Exclusion Criteria	-Participants who have received prior systemic treatment in the advanced or metastatic setting. -Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy. -Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note: Other protocol-defined inclusion/exclusion criteria may apply."
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Advanced or Metastatic HR+/HER2- Breast Cancer
Intervention(s)		-Experimental: Arm A: BGB-43395 + Letrozole -Active Comparator: Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Primary Outcome(s)		Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)

Primary Sponsor	BeOne Medicines Japan

Name of Certified Review Board	Tokyo Women's Medical University Hospital Institutional Review Board
Address	8-1 Kawada-cho, Shinjuku-ku,Tokyo, Tokyo
Approval Status	Approval
Date of approval	May. 08, 2026

Plan to share IPD	No

Secondary ID(s)	NCT07492641
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	United States/Australia/Malaysia/South Korea