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Locally Advanced Triple Negative Breast Cancer / BEBT-209 capsules / Gemcitabine Hydrochloride for Injection · Phase 2/3 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an active, randomized Phase 2b/Phase 3 trial evaluating BEBT-209 combined with carboplatin and gemcitabine versus chemotherapy alone in triple-negative breast cancer. No outcome data are posted in this record; the study is currently recruiting and results are not yet available.
Phase 2/3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Locally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer; Female; age from 18 Years; to 75 Years. Intervention: BEBT-209 plus CG. Compared with: Carboplatin plus Gemcitabine(CG) — Active Comparator. n = 446. 2 sites: China.
This is a registry record for an active, randomized Phase 2b/Phase 3 trial evaluating BEBT-209 combined with carboplatin and gemcitabine versus chemotherapy alone in triple-negative breast cancer. No outcome data are posted in this record; the study is currently recruiting and results are not yet available.
No results, efficacy data, or safety outcomes are reported in this registry record. No interim analysis results or safety signals are disclosed in this registry entry.
Once results are published, this trial will provide evidence on whether addition of BEBT-209 to standard chemotherapy improves response rates and survival in triple-negative breast cancer. Clinicians should not make treatment decisions based on this registry record alone, as no efficacy or safety data are currently reported.
This is a clinical trial registry record describing a planned Phase 2/3 interventional study with no results posted; the study is actively recruiting and outcome data have not yet been reported.
As stated by the source record.
Quoted from the source exactly as published.
Once results are published, this trial will provide evidence on whether addition of BEBT-209 to standard chemotherapy improves response rates and survival in triple-negative breast cancer. Clinicians should not make treatment decisions based on this registry record alone, as no efficacy or safety data are currently reported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07544056). This is a study registration, not published results. Lead sponsor: BeBetter Med Inc. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 446 participants (ESTIMATED). Conditions: Locally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer. Interventions: DRUG: BEBT-209 capsules; DRUG: Carboplatin Injection; DRUG: Gemcitabine Hydrochloride for Injection. Primary outcome measures: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Phase IIb) , From randomization until disease progression or end of treatment or death (up to 24 months).; Overall Survival (OS) (Phase III) , From randomization until death (up to 48 months).. Brief summary: Title: A Study to See if BEBT-209 Combined With Chemotherapy Works to Treat People With Triple-Negative Breast Cancer Researchers want to learn if a new drug called BEBT-209 works to treat people with a specific type of breast cancer. This cancer is called locally advanced or metastatic triple-negative breast cancer (TNBC). The study has two parts. In the first part, researchers want to see if the new drug combination can shrink tumors. In the second part, researchers want to see if this treatment helps people live longer. Researchers will put participants into two groups by chance. This is like flipping a coin. Group 1: Participants get BEBT-209 plus two chemotherapy drugs. These drugs are Carboplatin and Gemcitabine. Group 2: Participants get only the two chemotherapy drugs. Researchers will group people based on the treatments they had in the past. Researchers will also check: How long the treatment keeps the cancer from growing. This is called progression-free survival (PFS). If the treatment is safe. Researchers will look for adverse events (AE), such as low blood cell counts. How participants feel. This is called health-related quality of life (HRQoL). How the body uses the drug.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.