Trial · NCT07544056
A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT07544056, Phase 2, Phase 3, Recruiting, BeBetter Med Inc
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer. Trials, record NCT07544056. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07544056
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
- NCT number
- NCT07544056
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 446 participants, estimated
- Lead sponsor
- BeBetter Med Inc
- Conditions
- Locally Advanced Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- Interventions
- BEBT-209 capsules, Carboplatin Injection, Gemcitabine Hydrochloride for Injection
- First posted
- 2026-04-22
- Last updated
- 2026-08-18
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Phase IIb) | From randomization until disease progression or end of treatment or death (up to 24 months). | 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). |
| Primary | Overall Survival (OS) (Phase III) | From randomization until death (up to 48 months). | 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. |
| Secondary | 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). | 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. |
| Secondary | 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). | 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. |
| Secondary | 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). | 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. |
| Secondary | 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). | 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. |
| Secondary | Overall Survival (OS) (Phase IIb) | From randomization until death (up to 48 months). | Time from the date of randomization to the date of death due to any cause. This endpoint is applicable to Phase IIb. |
| Secondary | Change from Baseline in Health-Related Quality of Life (HRQoL) (Phase IIb and Phase III) | 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). | 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. |
| Secondary | Adverse Events (AE) and Serious Adverse Events (SAE) (Phase IIb and Phase III) | From signing of informed consent until 30 days after the last dose. | 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. |
| Secondary | Maximum Plasma Concentration (Cmax) of BEBT-209 and its major Metabolites | C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose). | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07544056
GET https://conductscience.org/api/trials/v1/NCT07544056/registered