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RecruitingLast updated: 18 May 2026

KANDELA-302: Testing a new medicine when given with hormone therapy, compared to other treatments, in people with HR+, HER2- advanced breast cancerAn 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

KANDELA-302

Clinical summary

Summary

This study is being done to find out how safe and how well a new treatment works for people with HR+, HER2-negative breast cancer.

You may be eligible if you have locally advanced or metastatic HR+, HER2- breast cancer and have not received prior systemic treatment for your advanced disease. Prior treatment for an earlier stage may be permitted, please speak to your doctor about whether you are eligible.

Eligible participants will be randomly allocated (by chance) to one of two treatment arms:

  • Arm A: BGB-43395 plus letrozole
  • Arm B: A targeted medicine of the Investigator's choice (either abemaciclib, palbociclib, or ribociclib) plus letrozole.

Conditions

This trial is treating people with locally advanced or metastatic HR+, HER2- breast cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

BeOne Medicines

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

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