Trial Profile

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

Status: Not yet recruiting

Phase of Trial: Phase III

Latest Information Update: 31 Mar 2026

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

Drugs BGB-43395 (Primary) ; Abemaciclib; Letrozole; Palbociclib; Ribociclib
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Sponsors BeOne Medicines

25 Mar 2026 Status changed from planning to not yet recruiting.
26 Feb 2026 According to BeOne Medicines media release, this trial is expected to initiate in 1H 2026.
27 May 2025 According to BeOne Medicines media release, BeiGene is now called BeOne Medicines

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com