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Locally Advanced Triple-negative Breast CancerPhase 2/3NCT07544056

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

A Phase 2/3 study testing BEBT-209 capsules, Carboplatin Injection and Gemcitabine Hydrochloride for Injection in people with Locally Advanced Triple-negative Breast Cancer and Metastatic Triple-negative Breast Cancer, run by BeBetter Med Inc at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
BEBT-209 capsules, Carboplatin Injection and Gemcitabine Hydrochloride for Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
2 sitesChina
Study dates
4 Jun 2026to Dec 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • 10.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).
  • 11.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.

Who cannot join

  • 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.
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  • Transplantation: Prior history of hematopoietic stem cell or bone marrow transplantation.
  • Prohibited concomitant medications (within 7 days prior to first dose):
  • 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).
  • 8.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.
  • 9.Hypersensitivity: Known or suspected hypersensitivity to BEBT-209, carboplatin, gemcitabine, or any of their excipients.
  • 10.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).
  • 11.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).
  • 12.Cardiovascular/cerebrovascular disease (within 6 months):
  • New York Heart Association (NYHA) Class III-IV congestive heart failure or uncontrolled heart failure/coronary artery disease;
  • Clinically significant arrhythmias (e.g., symptomatic atrial fibrillation/flutter) or NCI CTCAE v6.0 grade ≥ 3 arrhythmias;
  • Myocardial infarction, severe/unstable angina, stroke, transient ischemic attack (TIA), symptomatic pulmonary embolism, coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI);
  • Refractory hypertension: systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg despite ≥ 3 types of antihypertensive medications.
  • 13.Gastrointestinal issues: Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, gastrectomy, or any malabsorption syndrome that may impair BEBT-209 absorption.
  • 14.Active infections of clinical significance, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases, and active syphilis infection.
  • Active hepatitis B is defined as positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) with HBV DNA above the upper limit of normal (ULN) of the study center. Patients with HBV DNA quantification above the ULN are permitted to receive antiviral therapy prior to screening and may be enrolled once viral load decreases to within the normal range; however, anti-HBV therapy must be continued throughout the study period.
  • Active hepatitis C is defined as HCV RNA above the detection limit. Active syphilis infection is defined as positive treponemal antibody with positive nontreponemal test (rapid plasma reagin [RPR] or toluidine red unheated serum test [TRUST]).
  • 15.Diabetes: Poorly controlled diabetes (hemoglobin A1c (HbA1c) ≥ 8.5%). 16.Other malignancies: Other progressive malignancies or malignancies treated within the past 5 years (excluding cured basal/squamous cell skin cancer or cervical carcinoma in situ).
  • 17.Psychiatric/neurological conditions: Active suicidal ideation or behavior within 3 months; current neurological disorders ≥ NCI CTCAE v6.0 grade 2.
  • 18.General exclusion: Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, increases participant risk or interferes with study results.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kegang Jiang, Master contact

+86-18664786382

kjiang@bebettermed.com

China2 sites, 2 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Jiajing Tang, +86-19198021737, jiajing.tang@bebettermed.com

    Recruiting

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

    Guangzhou, Guangdong, 510120

    Yueying Liang, +86-13370266729, yueying.liang@bebettermed.com

    Recruiting

Other trials in China

About this study

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

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.

Read more

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.

Read the detailed description
  1. Study Overview This is a randomized, controlled, open-label, multi-center, Phase IIb/III study designed to systematically evaluate the efficacy and safety of BEBT-209 (a selective cyclin-dependent kinase 4/6 [CDK4/6] inhibitor) in combination with carboplatin and gemcitabine (CG) compared to CG alone. The study is conducted in patients with locally advanced or metastatic triple-negative breast cancer (TNBC).
  2. The trial is structured into two stages: Phase IIb (Proof of Concept): Primarily focused on assessing the objective response rate (ORR) in approximately 60 participants. Phase III (Confirmatory): A pivotal stage focused on overall survival (OS) in approximately 386 participants.
  3. Scientific Rationale: Triple-negative breast cancer remains a highly aggressive subtype with limited treatment options once initial therapies fail. BEBT-209 acts as a highly selective CDK4/6 inhibitor. By arresting the cell cycle at the G1 phase, BEBT-209 synchronizes tumor cells, making them more susceptible to chemotherapy-induced DNA damage. Preclinical and early-phase clinical data suggest that BEBT-209 not only enhances the sensitivity of TNBC cells to carboplatin and gemcitabine but also provides a myeloprotective effect, reducing chemotherapy-induced bone marrow suppression.
  4. Study Design and Intervention: Eligible participants are randomly assigned in a 1:1 ratio to either the experimental group or the control group via a central randomization system. Experimental Group: Participants receive BEBT-209 (150 mg, four times per cycle on Day 1 [D1], Day 2 [D2], Day 8 [D8], and Day 9 [D9]) combined with carboplatin (area under the curve [AUC] × [creatinine clearance {CrCl} + 25]) and gemcitabine (1000 mg/m²). The AUC value is set to 2 mg/mL/min in this study. Control Group: Participants receive carboplatin (2 [mg/mL/min] × [CrCl {mL/min} + 25]) and gemcitabine (1000 mg/m²) on Day 1 (D1) and Day 8 (D8) of each 21-day cycle.
  5. Stratification Factors: Phase IIb: Lines of prior therapy (1st-line vs. 2nd-line). Phase III: (1) Lines of prior systemic therapy; (2) Prior programmed cell death-1/programmed death-ligand 1 (PD-1/PD-L1, or PD-[L]1) inhibitor therapy (yes vs. no); (3) Prior TROP2 antibody-drug conjugate (ADC) therapy (yes vs. no).
  6. Assessment and Follow-up:

Tumor response is evaluated every 6 weeks for the first three assessments, then every 9 weeks, and eventually every 12 weeks after one year, based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 criteria.

Independent Review: An independent review committee (IRC) will perform a blinded central review of all imaging data to provide a baseline-independent assessment of ORR and progression-free survival (PFS).

Safety Monitoring: Safety is assessed through adverse events (AE), graded by Common Terminology Criteria for Adverse Events version 6.0 of the National Cancer Institute (NCI-CTCAE v6.0), physical exams, and laboratory monitoring. Special focus is placed on hematological toxicities (e.g., duration of severe neutropenia [DSN]).

Pharmacokinetics and Biomarkers:

A subset of participants in Phase IIb will undergo pharmacokinetics (PK) sampling. Exploratory analyses will investigate the relationship between biomarkers (e.g., PD-L1, BRCA1/2) and clinical outcomes.

Being tested
BEBT-209 capsules, Carboplatin Injection, Gemcitabine Hydrochloride for Injection
Keywords
BEBT-209, Metastatic Triple-Negative Breast Cancer, CDK4/6 Inhibitors, Chemotherapy, Phase IIb/III Clinical Study, Locally Advanced Triple-Negative Breast Cancer
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEBT-209 capsulesDrug

    Also called KCBI-0191

    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.

  • Carboplatin InjectionDrug

    Also called NSC 241240

    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.

  • Gemcitabine Hydrochloride for InjectionDrug

    Also called NSC 613327

    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.

Study groups in NCT07544056
Study groupRoleWhat they receive
Carboplatin plus Gemcitabine(CG)Active comparatorParticipants 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.
Receives: Drug: Carboplatin Injection; Drug: Gemcitabine Hydrochloride for Injection
BEBT-209 plus CGExperimentalThis 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.
Receives: Drug: BEBT-209 capsules; Drug: Carboplatin Injection; Drug: Gemcitabine Hydrochloride for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

    Measured: From randomization until death (up to 48 months).

Secondary outcomes (17)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. Overall Survival (OS) (Phase IIb)

    Time from the date of randomization to the date of death due to any cause. This endpoint is applicable to Phase IIb.

    Measured: From randomization until death (up to 48 months).

  6. Change from Baseline in Health-Related Quality of Life (HRQoL) (Phase IIb and Phase III)

    Change from Baseline in HRQoL. Assessed by Quality of Life Instruments for Cancer Patients-Breast Cancer (QLICP-BR) version 2.0 (v2.0) in both Phase IIb and Phase III.

    Measured: Baseline, then at each chemotherapy visit (every 21-day cycle), at the end of treatment, and every 3 months during follow-up until death or withdrawal (up to 24 months).

  7. Adverse Events (AE) and Serious Adverse Events (SAE) (Phase IIb and Phase III)

    Incidence, severity (graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 (v6.0), and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs) in the Phase IIb and Phase III.

    Measured: From signing of informed consent until 30 days after the last dose.

  8. Maximum Plasma Concentration (Cmax) of BEBT-209 and its major Metabolites

    The peak plasma concentrations (Cmax) of BEBT-209 and its major metabolites on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 2 (C1D2) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb pharmacokinetic (PK) substudy.

    Measured: C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose).

  9. Time to reach Cmax (Tmax) of BEBT-209 and its major metabolites

    The time to maximum plasma concentration (Tmax) of BEBT-209 and its major metabolites on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 2 (C1D2 ) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose).

  10. Terminal Elimination Half-life (t1/2) of BEBT-209 and its major metabolites

    The time required for the plasma concentration of BEBT-209 and its major metabolites to decrease by half on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 2 (C1D2 ) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose).

  11. Area Under the Concentration-Time Curve (AUC) of BEBT-209 and its major Metabolites

    PK parameters calculated from blood concentration-time curves of BEBT-209 and its major Metabolites, Includes AUC from 0 to 36 hours (AUC0-36h), AUC from 0 to last measurable concentration (AUC0-t), and AUC from 0 to infinity (AUC0-∞). Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: Cycle 1 Day 1 (C1D1 ) (pre-dose, 1h, 2h, 4h, 6h post-dose) and Cycle 1 Day 2 (C1D2) (1, 2, 4, 8, 12, 24, 36h post-dose).

  12. Steady-state Maximum Concentration (Cmin,ss) of BEBT-209 and its major metabolites

    The Cmin,ss of BEBT-209 and its major metabolites on Cycle 1 Day 8 (C1D8) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: C1D8 (pre-dose).

  13. Steady-state Maximum Concentration (Cmax,ss) of BEBT-209 and its main metabolites

    The maximum plasma concentration of BEBT-209 and its main metabolites observed during a dosing interval at steady state on Cycle 1 Day 8 (C1D8) and Cycle 1 Day 9 (C1D9) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: C1D8 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D9 (1, 2, 4, 8, 12, 24, 36h post-dose).

  14. Average Steady-state Plasma Concentration (Cav,ss) of BEBT-209 and its major metabolites

    The average concentration of BEBT-209 and its major metabolites in plasma over a dosing interval at steady state on Cycle 1 Day8 (C1D8) and Cycle 1 Day 9 (C1D9 ) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: C1D8 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D9 (1, 2, 4, 8, 12, 24, 36h post-dose).

  15. Steady-state Elimination Half-life (t1/2,ss) of BEBT-209 and its metabolites

    The terminal elimination half-life of BEBT-209 and its metabolites measured under steady-state conditions on Cycle 1 Day8 (C1D8) and Cycle 1 Day 9 (C1D9) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: C1D8 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D9 (1, 2, 4, 8, 12, 24, 36h post-dose).

  16. Area Under the Concentration-Time Curve steady-state (AUCss) of BEBT-209 and its Metabolites

    PK parameters calculated from blood concentration-time curves of BEBT-209 and its major Metabolites at steady-state, Includes AUC from 0 to last measurable concentration at steady-state (AUC0-t,ss), AUC from 0 to infinity at steady-state (AUC0-∞,ss). Applicable only to participants enrolled in the Phase IIb PK substudy.

    Measured: Cycle 1 Day8 (C1D8) (pre-dose, 1h, 2h, 4h, 6h post-dose) and Cycle 1 Day 9 (C1D9 ) (1, 2, 4, 8, 12, 24, 36h post-dose).

  17. Biomarker Analysis (Phase IIb and Phase III)

    Correlation of biomarker expression (e.g., programmed death-ligand 1 [PD-L1], Breast Cancer Gene 1/2 [BRCA1/2] mutation status) with clinical efficacy and safety outcomes

    Measured: Baseline and at disease progression (up to 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start4 Jun 2026
  3. Primary completionJun 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
446 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07544056
Sponsor's protocol ID
GBMT-209B-P02
Status last verified
Aug 2026
First submitted
13 Apr 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BEBT-209 capsules, Carboplatin Injection and Gemcitabine Hydrochloride for Injection in people with Locally Advanced Triple-negative Breast Cancer and Metastatic Triple-negative Breast Cancer, run by BeBetter Med Inc at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kegang Jiang, Master (+86-18664786382, kjiang@bebettermed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Phase IIb) (time frame: From randomization until disease progression or end of treatment or death (up to 24 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07544056.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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