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

NCT07544056 | Not Yet Recruiting Phase 2

• 1 other identifier: GBMT-209B-P02
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

BEBT-209; Metastatic Triple-Negative Breast Cancer; CDK4/6 Inhibitors; Chemotherapy; Phase IIb/III Clinical Study; Locally Advanced Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  From randomization until disease progression or end of treatment or death (up to 24 months).

• 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.

  From randomization until death (up to 48 months).

Secondary Outcomes (17)

• Objective Response Rate (ORR) per RECIST v1.1 (Phase III)

  From randomization until disease progression or end of treatment or death (up to 24 months).

• Progression-Free Survival (PFS) per RECIST v1.1 (Phase IIb and Phase III)

  From randomization until disease progression or end of treatment or death (up to 24 months).

• Disease Control Rate (DCR) per RECIST v1.1 (Phase IIb and Phase III)

  From randomization until disease progression or end of treatment or death (up to 24 months).

• Duration of Response (DoR) per RECIST v1.1 (Phase IIb and Phase III)

  From the date of the first documented objective response (CR or PR) until the first documented disease progression or death (up to 24 months).

• Overall Survival (OS) (Phase IIb)

  From randomization until death (up to 48 months).

Study Arms (2)

Carboplatin plus Gemcitabine(CG)

ACTIVE COMPARATOR

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.

Drug: Carboplatin Injection; Drug: Gemcitabine Hydrochloride for Injection

BEBT-209 plus CG

EXPERIMENTAL

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: 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. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: BEBT-209 capsules; Drug: Carboplatin Injection; Drug: Gemcitabine Hydrochloride for Injection

Interventions

BEBT-209 capsules DRUG

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.

Also known as: KCBI-0191

BEBT-209 plus CG

Carboplatin Injection DRUG

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.

Also known as: NSC 241240

BEBT-209 plus CG; Carboplatin plus Gemcitabine(CG)

Gemcitabine Hydrochloride for Injection DRUG

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.

Also known as: NSC 613327

BEBT-209 plus CG; Carboplatin plus Gemcitabine(CG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• 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).
• Prior therapy: Must have received at least one but no more than two prior systemic therapies for unresectable locally advanced or metastatic disease. Progression within 12 months of completion of neoadjuvant/adjuvant therapy is considered one line of systemic therapy.
• Measurable disease: At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with stable status within 2 weeks prior to screening (clinically insignificant decline).
• Life expectancy: At least 12 weeks.
• Organ function: Adequate organ and bone marrow function (no blood transfusion or growth factors within 2 weeks prior to screening):
• (1)Absolute neutrophil count (ANC) ≥ 1,500/mm³; (2) Platelets ≥ 100,000/mm³; (3) Hemoglobin ≥ 9 g/dL; (4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (or ≤ 5.0 × ULN with liver metastases); (5) Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN with liver metastases); (6) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault).
• Toxicity recovery: Prior anti-cancer therapy toxicities resolved to ≤ grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 (excluding alopecia or other stable toxicities deemed safe by the investigator).
• Contraception: Negative serum pregnancy test within 7 days before treatment for women of childbearing potential. Agree to use highly effective contraception during the study and for 6 months after the last dose.
• Note: The initial documentation of locally advanced or metastatic disease must be supported by biopsy, pathology, or imaging reports with specific dates. Systemic therapy includes systemic treatments for TNBC, such as chemotherapy, targeted therapy, and immunotherapy.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• 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.
• Effusion and cachexia: Uncontrolled moderate to large pleural, pericardial, or abdominal effusion requiring repeated drainage, or cachexia.
• Transplantation: Prior history of hematopoietic stem cell or bone marrow transplantation.
• Prohibited concomitant medications (within 7 days prior to first dose):
• (1) Strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers; (2) Medications known to significantly prolong the QT interval or cause torsades de pointes (e.g., quinidine, disopyramide, procainamide, sotalol).
• Washout periods for prior anti-tumor therapy: Radiotherapy or oral small-molecule targeted therapy within 14 days; cytotoxic chemotherapy within 21 days; systemic anti-tumor therapies (e.g., macromolecules, immune checkpoint inhibitors, antibody-drug conjugates (ADCs)) within 28 days; cell therapy within 3 months.
• Hypersensitivity: Known or suspected hypersensitivity to BEBT-209, carboplatin, gemcitabine, or any of their excipients.
• Cardiac abnormalities: Significant electrocardiogram (ECG) abnormalities: QTcF \> 480 msec (based on the mean of triplicate ECGs if the first is \>480 msec); History of long QT syndrome (personal or family); Clinically significant ventricular arrhythmia or current use of anti-arrhythmic drugs/implantable cardioverter-defibrillator (ICD).
• Electrolyte imbalance: Uncontrolled electrolyte disturbances (e.g., hypocalcemia \<1.0 mmol/L, hypokalemia \<3.0 mmol/L, hypomagnesemia \<0.5 mmol/L) that increase QTc prolongation risk (re-screening allowed after intervention).
• Cardiovascular/cerebrovascular disease (within 6 months):
• New York Heart Association (NYHA) Class III-IV congestive heart failure or uncontrolled heart failure/coronary artery disease;

Sponsors & Collaborators

• BeBetter Med Inc: lead
• Hunan Cancer Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (2)

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

Guangzhou, Guangdong, 510120, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin; Gemcitabine; Injections

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Quchang Ouyang, PhD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Qiang Liu, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kegang Jiang, Master

CONTACT

+86-18664786382; kjiang@bebettermed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, open-label, active-controlled, parallel-assignment study consisting of a Phase IIb proof-of-concept (PoC) stage and a Phase III confirmatory stage. Eligible participants are randomized 1:1 to either the experimental arm (BEBT-209 in combination with carboplatin and gemcitabine) or the control arm (carboplatin and gemcitabine). The dosing regimens will tentatively remain the same across both study stages. Following the availability of preliminary efficacy and safety data of Phase IIb PoC stage, the study design for the confirmatory Phase III will be discussed with the Centerfor drug evaluation, NMPA (CDE).

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (2)