Clinical trial NCT07544056: A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Official title: A Randomized, Controlled, Open-label, Multi-center, Phase IIb/III Clinical Study to Evaluate BEBT-209 Plus Carboplatin and Gemcitabine Versus Carboplatin Plus Gemcitabine in Locally Advanced or Metastatic Triple-Negative Breast Cancer
Conditions: Locally Advanced Triple-negative Breast Cancer
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.
Interventions:
description: 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.<br/>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.<br/>Duration: Treatment continues until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.<br/>Dose adjustment: Dose reductions for BEBT-209 are not permitted.
name: BEBT-209 capsules
other_name: KCBI-0191
type: Drug
description: Dosage: Intravenous infusion at AUC 2 (Calvert formula: 2 (mg/mL/min) × [CrCl (mL/min) + 25]).<br/>Schedule: Administered on Day 2 and Day 9 (experimental arm) or Day 1 and Day 8 (control arm) of each 21-day cycle.<br/>Precautions: Must be diluted with 5% glucose. Do not use equipment containing aluminum.<br/>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.
name: Carboplatin Injection
other_name: NSC 241240
type: Drug
description: 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.<br/>Preparation: Diluted with 0.9% sodium chloride (with a gemcitabine concentration of ≤40 mg/mL); do not refrigerate after dilution.<br/>Dose adjustment: May be reduced to 800 mg/m² based on toxicity. If delay exceeds 42 days, treatment must be discontinued.
name: Gemcitabine Hydrochloride for Injection
other_name: NSC 613327
type: Drug
Study arms:
design_group_description: Participants in this arm will receive carboplatin (2 [mg/mL/min] × [CrCl (mL/min) + 25]) and gemcitabine (1000 mg/m²) in 21-day cycles. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.
design_group_title: Carboplatin plus Gemcitabine(CG)
design_group_type: Active Comparator
design_group_description: This is a phase IIb/III study. Participants in this arm will receive BEBT-209 150 mg orally on Days 1, 2, 8, and 9 of each 21-day cycle, administered as follows:<br/>Days 1 and 8: BEBT-209 administered at least 30 minutes before dinner Days 2 and 9 (chemotherapy days): BEBT-209 administered at least 30 minutes before breakfast, followed by carboplatin (2 [mg/mL/min] × [CrCl (mL/min) + 25]) and gemcitabine (1000 mg/m²) intravenously; the interval between BEBT-209 dosing and chemotherapy initiation is 4 hours ± 0.5 hours.<br/>Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.
design_group_title: BEBT-209 plus CG
design_group_type: Experimental
Sponsor: BeBetter Med, Inc.
Collaborators: Hunan Cancer Hospital
Sun Yat-Sen Memorial Hospital
Drug name mappings:
name: BEBT-209
lang: EN
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP