A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorBeBetter Med Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BEBT-209 capsules
DrugDosage: 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.
Carboplatin Injection
DrugDosage: 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.
Gemcitabine Hydrochloride for Injection
DrugDosage: 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.
Treatment groups
446 Participants
are divided into 2 treatment groupsGroup A: Carboplatin plus Gemcitabine(CG)Active comparator 2 interventions
Group B: BEBT-209 plus CGExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Phase IIb)
Percentage of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1. This is the primary endpoint for the Phase IIb and will be assessed by both independent review committee (IRC) and investigator (INV).
Time frame
From randomization until disease progression or end of treatment or death (up to 24 months).2
Overall Survival (OS) (Phase III)
Defined as the time from the date of randomization to the date of death due to any cause. This is the primary endpoint for the Phase III.
Time frame
From randomization until death (up to 48 months).Secondary outcomes
1
Objective Response Rate (ORR) per RECIST v1.1 (Phase III)
Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1. Assessed by both IRC and INV for the Phase III.
Time frame
From randomization until disease progression or end of treatment or death (up to 24 months).2
Progression-Free Survival (PFS) per RECIST v1.1 (Phase IIb and Phase III)
Time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause. Assessed by both IRC and INV for the Phase IIb and Phases III.
Time frame
From randomization until disease progression or end of treatment or death (up to 24 months).3
Disease Control Rate (DCR) per RECIST v1.1 (Phase IIb and Phase III)
Percentage of participants achieving CR, PR, or stable disease (SD) per RECIST v1.1. Assessed by both IRC and INV for the Phase IIb and Phases III.
Time frame
From randomization until disease progression or end of treatment or death (up to 24 months).4
Duration of Response (DoR) per RECIST v1.1 (Phase IIb and Phase III)
Time from the first documented objective response (CR or PR) to the first documented disease progression or death. Assessed by both IRC and INV for the Phase IIb and Phases III.
Time frame
From the date of the first documented objective response (CR or PR) until the first documented disease progression or death (up to 24 months).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
BeBetter Med Inc
Lead sponsor
Hunan Cancer Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov