Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06685796

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

Led by BeBetter Med Inc · Updated on 2024-11-13

120

Participants Needed

2

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Willing and able to sign informed consent
  • Diagnosed with HR-negative, HER2-negative locally recurrent or metastatic breast cancer confirmed by biopsy
  • Tumor tissue shows estrogen and progesterone receptor negative (<1% nuclear staining) and HER2 negative
  • Previously received 1-2 lines of systemic treatment
  • At least one measurable lesion according to RECIST 1.1
  • ECOG performance status of 0 or 1 with no recent decline
  • Life expectancy of at least 12 weeks
  • Adequate organ and bone marrow function as defined by blood counts and liver/kidney tests
  • Resolved acute toxic reactions from prior treatments to baseline or grade 1 or lower
  • Negative pregnancy test and agreement to use effective contraception if of childbearing potential
Not Eligible

You will not qualify if you...

  • Previous treatment with gemcitabine
  • Previous carboplatin treatment allowed only if given >6 months before metastatic relapse
  • Active central nervous system metastases requiring immediate treatment
  • Prior hematopoietic stem cell or bone marrow transplant
  • Recent use of strong CYP3A4 inhibitors/inducers or drugs prolonging QT interval
  • Recent radiotherapy or investigational drug treatment within specified timeframes
  • Allergy or hypersensitivity to BEBT-209, carboplatin, or gemcitabine
  • Prolonged QT interval or history/family history of long QT syndrome or significant arrhythmias
  • Uncontrolled electrolyte imbalances affecting QTc
  • History of serious heart conditions including myocardial infarction or heart failure
  • Active gastrointestinal conditions affecting drug absorption
  • Active infections including hepatitis B, hepatitis C, or HIV/AIDS
  • Poorly controlled diabetes
  • Plans to conceive within 5 years without prior oocyte cryopreservation
  • Recent or active suicidal ideation or behavior
  • Current participation in other interventional clinical trials
  • Other serious medical or psychiatric conditions that increase risk or affect study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

2

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

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Research Team

K

Kegang Jiang, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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