> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/bgb-43395-plus-letrozole-versus-cdk4-6i-plus-letrozole-for-f52db3b5-9b59-4e34-8580-646935f100d3 > Record changed: 2026-10-13 # 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 NCT07492641 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) Participants 1,056 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) Lead sponsor BeOne Medicines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) Start date 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) Number of sites 108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Title and summary **Summary** The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Acronym** KANDELA-302 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Dates **Completion date** 2037-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **First posted** 2026-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Primary completion date** 2029-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Start date** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Size and sites **Participants** 1,056 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Planned participants** 1,056 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Number of sites** 108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Lead sponsor** BeOne Medicines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Identifiers **Registry ID** NCT07492641 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **ClinicalTrials.gov ID** NCT07492641 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Outcomes ### Primary outcomes 1. Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) Timeframe: Up to approximately 4 years PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to approximately 11 years OS is defined as the time from the date of randomization until the date of death due to any cause. 2. Overall Response Rate (ORR) Timeframe: Up to approximately 4 years ORR is defined as the percentage of participants who had a complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1. 3. Duration of Response (DOR) Timeframe: Up to approximately 4 years DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first, as assessed by BICR per RECIST v1.1. 4. PFS Determined by Investigator Timeframe: Up to approximately 4 years PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 5. Clinical Benefit Rate (CBR) Timeframe: Up to approximately 4 years CBR is defined as the percentage of participants who have a CR, PR, or stable disease maintained for ≥ 24 weeks after randomization (without subsequent anticancer treatment) per RECIST v1.1 . 6. Time to Response (TTR) Timeframe: Up to approximately 4 years TTR is defined as the time from treatment initiation to the first response confirmed by BICR per RECIST v1.1. 7. Number of Participants with Adverse Events (AEs) Timeframe: From first dose of study drug up to 30 days after last dose, up to approximately 11 years Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results. 8. Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454. Timeframe: Baseline and up to approximately 4 years The EORTC-IL454 is a questionnaire that asks participants to rate their breast cancer symptoms and the impact of breast cancer on their quality of life (QoL). The EORTC-IL454 is an EORTC Item Library-derived scale set constructed using items from the validated EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) (a core measure of health-related QoL in cancer patients) and the QLQ-BR23 (its breast cancer-specific module) The EORTC-IL454 contains 26 questions, each answered on a 4-point scale (1 = Not at all; 4 = Very much), and includes 2 functional scales (physical functioning and role functioning), 2 symptom scales (Nausea/Vomiting and Diarrhea), and 1 Global Health Status (GHS)/Quality of Life (QoL) scale, 7 systemic side effects scales, 3 arm symptom scales, and 4 breast-specific symptom scales. The recall period is the past 7 days. Higher scores in GHS and functional scales and lower scores in symptom scales indicate better QoL. 9. Progression-Free Survival 2 (PFS2) Timeframe: Up to approximately 4 years PFS2 is defined as the time from randomization until progression on the next line of treatment (ie, first subsequent therapy), as assessed by the investigator, or death due to any cause, whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Sites - Alabama Oncology PrincetonBirmingham, United StatesRecruiting - Alaska Oncology and Hematology, LlcAnchorage, United StatesRecruiting - Ironwood Cancer and Research Centers Chandler IiChandler, United StatesRecruiting - Genesis Cancer and Blood Institute Hot Springs (Harmony Park)Hot Springs, United StatesRecruiting - Helios Clinical Research the Oncology Institute Fountain ValleyFountain Valley, United StatesRecruiting - Ventura County Hematology Oncology SpecialistsOxnard, United StatesRecruiting - Brcr Coral SpringsCoral Springs, United StatesRecruiting - Mid Florida Hematology and Oncology CenterOrange City, United StatesRecruiting - Florida Clinical Trials Group PlantationPlantation, United StatesRecruiting - Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, United StatesRecruiting - Florida Clinical Trials Group TamaracTamarac, United StatesRecruiting - Hope and Healing Cancer ServicesHinsdale, United StatesRecruiting - Cancer Care Specialists For IllinoisOFallon, United StatesRecruiting - Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesRecruiting - Mercy Medical CenterCedar Rapids, United StatesRecruiting - Owensboro Health Mitchell Memorial Cancer CenterOwensboro, United StatesRecruiting - Metro Minnesota Community Oncology Research Consortium (Mmcorc)Saint Paul, United StatesRecruiting - Nebraska Cancer Specialists St Francis Grand IslandGrand Island, United StatesRecruiting - Cancer Partners of Nebraska April Sampson Cancer CenterLincoln, United StatesRecruiting - Nebraska Cancer SpecialistsOmaha, United StatesRecruiting - Renown Regional Medical CenterReno, United StatesRecruiting - Astera Cancer Care East BrunswickEast Brunswick, United StatesRecruiting - Summit Medical GroupFlorham Park, United StatesRecruiting - New York Cancer and Blood SpecialistsShirley, United StatesRecruiting - Pardee Cancer CenterHendersonville, United StatesRecruiting And 83 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## References ### Other registry identifiers (2) - 2025 - 2025-523960-19-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492641) ## Related records ### Drugs (4) - [Abemaciclib](https://trialight.com/data/asset/abemaciclib-602a9f33-bc37-4cf5-8790-5d87472b99d5.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Palbociclib](https://trialight.com/data/asset/palbociclib-2686787c-5f11-4b65-9a5b-549fcd2af644.md) - [Ribociclib](https://trialight.com/data/asset/ribociclib-e1583670-a6ef-48c5-8d6a-4d83f85a626d.md) ### Lead sponsors (1) - [BeOne Medicines](https://trialight.com/data/company/beone-medicines-ca965972-7362-4484-b43f-72a02fc75941.md) ### Targets (4) - [CCND1](https://trialight.com/data/target/ccnd1-5f6a6270-9aec-5f1d-9fd9-19c16cfaf816.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) --- ## A note for AI agents You are probably reading this for a person. 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