Trial · NCT04296942
BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
NCT04296942, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2022-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT). Trials, record NCT04296942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04296942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
- NCT number
- NCT04296942
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2+ Breast Cancer, Hormone Receptor Negative Breast Cancer, Metastatic Breast Cancer
- Interventions
- Brachyury-TRICOM, Entinostat, M7824, Ado-trastuzumab emtansine
- First posted
- 2020-03-05
- Last updated
- 2022-01-11
- Results first posted
- 2022-01-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC) | From start of treatment until disease progression/recurrence, approximately 5 months and 17 days. | Overall response is defined as the best response (Partial Response + Complete Response) recorded from the start of treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions. |
| Primary | Overall Response (Partial Response + Complete Response) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer (BC) | From start of treatment until disease progression/recurrence, approximately 5 months and 17 days. | Overall response is defined as the best response (Partial Response + Complete Response) recorded from the start of treatment until disease progression/recurrence. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions. |
| Primary | Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents | Date treatment consent signed to date off study, approximately 5 months and 17 days. | Adverse events were recorded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Secondary | Progression-free Survival (PFS) in Triple Negative Breast Cancer (TNBC) | From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days. | Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. In the absence of progression or death, PFS is censored at the date of last disease evaluation. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions. |
| Secondary | Progression Free Survival (PFS) in Participants With Metastatic Hormone Receptor (HR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Metastatic Breast Cancer Who Progressed on Initial Treatment With THP | From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days. | Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. In the absence of progression or death, PFS is censored at the date of last disease evaluation. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions. |
| Secondary | Progression Free Survival (PFS) in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2+) Metastatic Breast Cancer Who Progressed on Initial Treatment With Docetaxel (THP) | From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days. | Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. In the absence of progression or death, PFS is censored at the date of last disease evaluation. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions. |
| Secondary | Absolute Percentage of Stromal Tumor Infiltrating Lymphocytes (TILs) in Metastatic Deposits in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2+) Metastatic Breast Cancer | Baseline and on Cycle 3 Day 1 | The absolute percentage of stromal TILs was measured by the Salgado method in metastatic deposits in participants with metastatic HER2+ metastatic breast cancer. The Salgado method is a standardized approach for measuring the percentage of stromal TILs in primary breast tumor specimens before therapy, using visual assessment of standard hematoxylin and eosin (H\&E)-stained sections. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 5 months and 17 days. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC) | From start of treatment until disease progression/recurrence, approximately 5 months and 17 days. | This outcome measure pertains to Arm 1 TNBC participants only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response (Partial Response + Complete Response) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer (BC) | From start of treatment until disease progression/recurrence, approximately 5 months and 17 days. | This outcome measure pertains to Arm 2 and 3 only. Overall response in the HER2+ breast cancer cohort was not assessed as the study closed to accrual and no participants with HER2+ breast cancer was accrued. | ||
| PRIMARY | Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents | Date treatment consent signed to date off study, approximately 5 months and 17 days. | No participants were enrolled in group 2 and 3 due to study closure by the sponsor. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) in Triple Negative Breast Cancer (TNBC) | From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days. | This outcome measure pertains to Arm 1 TNBC participants only. | Days | NUMBER |
| SECONDARY | Progression Free Survival (PFS) in Participants With Metastatic Hormone Receptor (HR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Metastatic Breast Cancer Who Progressed on Initial Treatment With THP | From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days. | This outcome measure pertains to Arm 2 and 3 only. PFS in the HER2+ breast cancer cohort was not assessed as the study closed to accrual and no participants with HER2+ breast cancer was accrued. | ||
| SECONDARY | Progression Free Survival (PFS) in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2+) Metastatic Breast Cancer Who Progressed on Initial Treatment With Docetaxel (THP) | From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days. | This outcome measure pertains to Arm 2 and 3 only. PFS in the HER2+ breast cancer cohort was not assessed as the study closed to accrual and no participants with HER2+ breast cancer was accrued. | ||
| SECONDARY | Absolute Percentage of Stromal Tumor Infiltrating Lymphocytes (TILs) in Metastatic Deposits in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2+) Metastatic Breast Cancer | Baseline and on Cycle 3 Day 1 | This outcome measure pertains to Arm 2 and 3 only. No participants with HER2+ metastatic breast cancer was accrued and thus outcome measure is not possible to determine. | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 5 months and 17 days. | No participants were enrolled in group 2 and 3 due to study closure by the sponsor. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC) | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | Complete Response | 0 | Participants | |
| Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC) | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | Partial Response | 0 | Participants | |
| Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC) | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | Progressive Disease | 1 | Participants | |
| Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | Grade 3 | 0 | Participants | |
| Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | Grade 4 | 0 | Participants | |
| Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | Grade 5 | 0 | Participants | |
| Progression-free Survival (PFS) in Triple Negative Breast Cancer (TNBC) | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 63 | Days | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | |
| Overall Study | STARTED | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | |
| Overall Study | STARTED | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | |
| Overall Study | COMPLETED | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 0 | |
| Overall Study | COMPLETED | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | |
| Overall Study | COMPLETED | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | |
| Overall Study | NOT COMPLETED | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | |
| Overall Study | NOT COMPLETED | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | |
| Overall Study | NOT COMPLETED | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | 1 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | 0 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | 0 | 0 |
| other | Anemia | Blood and lymphatic system disorders | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | 1 | 1 |
| other | Anemia | Blood and lymphatic system disorders | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | 0 | 0 |
| other | Anemia | Blood and lymphatic system disorders | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | 0 | 0 |
| other | Constipation | Gastrointestinal disorders | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | 1 | 1 |
| other | Constipation | Gastrointestinal disorders | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | 0 | 0 |
| other | Constipation | Gastrointestinal disorders | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | 0 | 0 |
| other | Fatigue | General disorders | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | 1 | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | 1 |
| Total, all-cause mortality | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | 0 |
| Total, all-cause mortality | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | 0 |
| Total, other adverse events | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 1 | 1 |
| Total, other adverse events | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | 0 |
| Total, other adverse events | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | 0 |
| Total, serious adverse events | 1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury | 0 | 1 |
| Total, serious adverse events | 2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1) | 0 | 0 |
| Total, serious adverse events | 3/M7824 + BN-Brachyury + T-DM1 + Entinostat | 0 | 0 |
Source ClinicalTrials.gov
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT04296942
GET https://conductscience.org/api/trials/v1/NCT04296942/events?page=2