Observational Study of BRAF Inhibitor Combination Therapy for BRAF mutant Metastatic Colorectal Cancer including Biomarker Research: BEETS trial(JACCRO CC-18)

Conditions

Colorectal Cancer

Chiaki Inagaki, Ryo Matoba, Eisuke Inoue, Daisuke Kotani, Tadamichi Denda et al. (20 authors)

Journal of Clinical Oncology2026-05-27

10.1200/jco.2026.44.16_suppl.3540

Real-world outcomes of encorafenib, cetuximab ± binimetinib for BRAF‑mutated metastatic colorectal cancer: The BEETS (JACCRO CC‑18) study.

Kotani D, Inoue E, Denda T, Inagaki C, Kashiwada T, Mihara Y, Sugaya A, Suwa Y, Ohta T, Kuramochi H, Oshima K, Yuki S, Shiozawa M, Tsuji A, Muro K, Ichikawa W, Fujii M, Sunakawa Y.

2026-02-27

10.1093/oncolo/oyag068

Encorafenib and cetuximab with/without binimetinib therapies for patients with <i>BRAF</i> -mutated metastatic colorectal cancer with prognostic factors: The BEETS trial (JACCRO CC-18).

Yu Sunakawa, Eisuke Inoue, Daisuke Kotani, Tadamichi Denda, Chiaki Inagaki et al. (18 authors)

Journal of Clinical Oncology2025-01-27

10.1200/jco.2025.43.4_suppl.164

The BEETS (JACCRO CC-18) Trial: An Observational and Translational Study of <i>BRAF</i> -Mutated Metastatic Colorectal Cancer

Chiaki Inagaki, Ryo Matoba, Satoshi Yuki, Manabu Shiozawa, Akihito Tsuji et al. (10 authors)

Future Oncology2023-06-012 citations

10.2217/fon-2023-0209

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with colorectal cancer confirmed as adenocarcinoma by pathological examination (histology) and BRAF mutation by examination using tumor tissue (2) Patients who will receive BRAF inhibitor combination therapy as second- or third-line treatment (3) Patients with ECOG performance status of 0 to 2 (4) Patients aged 20 years or older (5) Patients with measurable or evaluable lesions by RECISTver1.1

Exclusion criteria

Exclusion criteria: (1) Patients with interstitial pneumonia or pulmonary fibrosis (2) Patients with a history of acute myocardial infarction or acute coronary syndrome (unstable angina, coronary artery bypass surgery, coronary angioplasty, stenting, etc.) within 6 months prior to enrollment (3) Patients with a history or current evidence of clinically significant congestive heart failure or cardiac arrhythmia within 6 months prior to enrollment (4) Patients with a history of clinically significant thromboembolic or cerebrovascular events within 6 months prior to enrollment (5) Patients with a history of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive drugs or surgery) within 12 months prior to enrollment (6) Patients with active multiple cancers (7) Patients with active infectious diseases that require systemic treatment (8) Patients with positive HBs antigen, HCV antibody, or HIV antibody (9) Patients judged by the principal investigator or sub-investigator to be inappropriate for the safe conduct of this study

Design outcomes

Primary

Measure	Time frame
Overall survival Relationship between treatment outcomes of BRAF inhibitor combination therapy and genomic data on pretreatment ctDNA and RNA analysis	—

Secondary

Measure	Time frame
Response rate Disease control rate Tumor shrinkage rate Time to response Duration of response Progression-free survival Safety	—

Countries

Japan

Contacts

Public ContactYu Sunakawa

St. Marianna University School of Medicine Department of Clinical Oncology

y.sunakawa@marianna-u.ac.jp0449778111

Outcome results