A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

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.

Conditions

• Locally Advanced Triple-negative Breast Cancer
• Metastatic Triple-negative Breast Cancer

Interventions

DRUG

BEBT-209 capsules

Dosage: 150 mg orally per dose. Schedule: Administered on Day 1 (D1; before dinner), Day 2 (D2; before breakfast), Day 8 (D8; before dinner), and Day 9 (D9; before breakfast) of each 21-day cycle. Timing: On chemotherapy days (D2 and D9), BEBT-209 must be taken at least 30 minutes before breakfast and exactly 4 hours (±0.5 hours) prior to the start of chemotherapy. Duration: Treatment continues until progressive disease (PD), unacceptable toxicity, or withdrawal of consent. Dose adjustment: Dose reductions for BEBT-209 are not permitted.

DRUG

Carboplatin Injection

Dosage: Intravenous infusion at AUC 2 (Calvert formula: 2 (mg/mL/min) × \[CrCl (mL/min) + 25\]). Schedule: Administered on Day 2 and Day 9 (experimental arm) or Day 1 and Day 8 (control arm) of each 21-day cycle. Precautions: Must be diluted with 5% glucose. Do not use equipment containing aluminum. Dose adjustment: May be reduced to AUC 1.5 (Calvert formula: 1.5 (mg/mL/min) × \[CrCl (mL/min) + 25\]) based on hematological toxicity. If delay exceeds 42 days, treatment must be discontinued.

DRUG

Gemcitabine Hydrochloride for Injection

Dosage: Intravenous infusion at 1000 mg/m². Schedule: Administered on Day 2 and Day 9 (experimental arm) or Day 1 and Day 8 (control arm) of each 21-day cycle. Preparation: Diluted with 0.9% sodium chloride (with a gemcitabine concentration of ≤40 mg/mL); do not refrigerate after dilution. Dose adjustment: May be reduced to 800 mg/m² based on toxicity. If delay exceeds 42 days, treatment must be discontinued.

Sponsors & Collaborators

• Hunan Cancer Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• BeBetter Med Inc

  lead INDUSTRY

Principal Investigators

• Quchang Ouyang, PhD · Hunan Cancer Hospital

• Qiang Liu, PhD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-04

Primary Completion

2030-06-30

Completion

2030-12-31

Countries

• China

Study Locations