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.
Age and gender: Female, aged 18 to 75 years (inclusive).
Informed consent: Voluntarily signed the written informed consent form (ICF).
Diagnosis: Pathologically confirmed hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic triple-negative breast cancer (TNBC).
HR-negative: <1% of nuclei stain positive for estrogen receptor (ER) and progesterone receptor (PR) by immunohistochemistry (IHC). HER2-negative: IHC 0, 1+, or IHC 2+ with negative in situ hybridization (ISH).
Prior treatment history: Prior treatment with gemcitabine.
Prior treatment with carboplatin for unresectable locally recurrent or metastatic breast cancer (unless completed in the (neo)adjuvant setting >6 months prior to first metastatic relapse).
Central nervous system (CNS) metastases: Known CNS metastases or leptomeningeal disease (including leptomeningeal metastases, spinal cord metastases, spinal cord compression, and unstable brain metastases). Participants with stable brain metastases (clinically/radiographically stable for at least 4 weeks) are eligible.
Pulmonary conditions: Clinically significant pulmonary diseases (e.g., pulmonary embolism within 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, significant pleural effusion) or autoimmune/inflammatory diseases with lung involvement. Current interstitial lung disease (ILD)/pneumonitis requiring systemic steroids, or active ILD/pneumonitis suggested by baseline imaging.
BeBetter Med Inc
Lead sponsor
Hunan Cancer Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator