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A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer

NCT06685796 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-11-13

No results posted yet for this study

Summary

This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).

Conditions

  • Advanced Triple-Negative Breast Cancer

Interventions

DRUG

BEBT-209 capsules

BEBT-209 Capsules, dosage: 150mg, frequency and duration of administration: administered on days 1, 2, 8, and 9 of each cycle, with a 21-day cycle. On days 1 and 8, take orally once before dinner or twice (before breakfast and before dinner), and on days 2 and 9, take orally once before breakfast.

DRUG

Carboplatin injection

Carboplatin injection, dosage: AUC 2 × (creatinine clearance rate + 25), frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.

DRUG

Gemcitabine hydrochloride for injection

Gemcitabine hydrochloride for injection, dosage: 1000mg/m², frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.

Sponsors & Collaborators

  • 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
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06685796 on ClinicalTrials.gov