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BGB-43395 Plus Letrozole versus CDK4/6i Plus Letrozole for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (BeOne/KANDELA-302)

Short Title: BGB-43395

Enrollment Status: Recruiting

NCT #: NCT07492641

Specialty Area: Oncology

Condition Studied: Advanced or Metastatic HR+/HER2- Breast Cancer

Age Groups: Adult; Older Adult

Study Information

Summary / Purpose

To compare the effectiveness and safety of BGB-43395 in combination with letrozole or an investigator-selected approved CDK4/6 inhibitor for adults with advanced or metastatic HR-positive/HER2-negative breast cancer who have not previously received systemic anticancer treatment for advanced or metastatic disease.

Study Type: Interventional

Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:

Adults 18+ years of age
Confirmed HR-positive/HER2-negative advanced or metastatic breast cancer
No prior systemic anticancer treatment for advanced or metastatic disease
Must have an ECOG performance status of 0–1 and either measurable disease by RECIST v1.1 or evaluable bone disease
Visceral metastases may be eligible, but those with visceral crisis are excluded

What's Involved

Participation in the study will include:

Random assignment to receive either BGB-43395 plus letrozole or an investigator-selected CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) plus letrozole.
Attending regular clinic visits
Tumor imaging, laboratory testing, and safety assessments to monitor treatment response and side effects

Principal Investigator

Lee Schwartzberg, MD

Oncology

Conrad Breast Center at South Meadows

(775) 982–5000

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Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT07492641

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.