Phase 2 Trial of BEBT-209 Plus Chemotherapy for Triple-Negative Breast Cancer
Summary
The NIH has registered a new Phase 2 clinical trial (NCT07544056) evaluating BEBT-209 capsules in combination with Carboplatin and Gemcitabine chemotherapy for patients with locally advanced or metastatic triple-negative breast cancer. Participants will be randomized to receive either the BEBT-209 drug combination or chemotherapy alone, with researchers measuring tumor response, progression-free survival, and treatment safety. The trial began April 22, 2026, and represents an investigational study of an experimental oncology compound.
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
The NIH has registered a new Phase 2 clinical trial on ClinicalTrials.gov, expanding the clinical research landscape for triple-negative breast cancer treatment. The study will enroll patients with locally advanced or metastatic TNBC and randomly assign them to receive either BEBT-209 combined with Carboplatin and Gemcitabine or chemotherapy alone.
Healthcare providers, clinical investigators, and patients seeking trial options for triple-negative breast cancer should be aware of this ongoing Phase 2 evaluation. Sponsors and researchers conducting competing or complementary oncology trials should note this registration as part of the competitive clinical development landscape for breast cancer therapeutics.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Phase 2 NCT07544056 Kind: PHASE2 Apr 22, 2026
Abstract
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.
Conditions: Locally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer
Interventions: BEBT-209 capsules, Carboplatin Injection, Gemcitabine Hydrochloride for Injection
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