Trial · NCT02708680
Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
NCT02708680, Phase 1, Phase 2, Completed, Syndax Pharmaceuticals; results first posted 2023-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In. Trials, record NCT02708680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02708680
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
- NCT number
- NCT02708680
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Syndax Pharmaceuticals
- Conditions
- Breast Cancer
- Interventions
- Entinostat, Atezolizumab, Placebo
- First posted
- 2016-03-15
- Last updated
- 2024-12-04
- Results first posted
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Participants Experiencing DLT | Up to 21 days after Cycle 1 Day 1 | Phase 1b employed a classical 3+3 design, with the determination of DLT based on entinostat in combination with atezolizumab within the first cycle of treatment (that is, between Day 1 to Day 21 of Cycle 1). Six participants were required to be treated in a dose level for it to be considered MTD or the Recommended Phase 2 Dose (RP2D). A DLT was defined as the occurrence of specific events, defined in the protocol, that were considered by the investigator to be at least possibly related to study drug using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03.The DLT assessment window (Cycle 1) was the time period between Cycle 1 Day 1 until Cycle 2 Day 1 (expected to be 21 days after Cycle 1 Day 1). |
| Primary | Phase 1b: Determination of the RP2D | Up to 21 days after Cycle 1 Day 1 | Phase 1b employed a classical 3+3 design, with the determination of the RP2D based on entinostat in combination with atezolizumab within the first cycle of treatment (that is, between Day 1 to Day 21 of Cycle 1). The RP2D was defined as equal to or less than the preliminary maximum tolerated dose (MTD) and was determined in discussion with the sponsor, the study medical monitor, and dose determination phase investigators. The MTD was defined as the highest dose level at which \<33% of 6 participants experience DLT. |
| Primary | Phase 2 Expansion: Duration of Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to 1 year | The duration of PFS, assessed using RECIST 1.1, was used to evaluate the efficacy of entinostat at the RP2D in combination with atezolizumab in participants with advanced triple negative breast cancer (aTNBC). It was defined as the number of months from randomization to the earlier of progressive disease or death due to any cause. One month was considered 30.4375 days. PFS (months) = (Date of Progression or Censoring - Date of Randomization + 1)/30.4375. |
| Secondary | Phase 2 Expansion: Duration of PFS Using Immune Response RECIST (irRECIST) | Up to 1 year | The duration of PFS, assessed using irRECIST, was used to evaluate the efficacy of entinostat at the RP2D in combination with atezolizumab in participants with aTNBC. It was defined as the number of months from randomization to the earlier of progressive disease or death due to any cause. One month was considered 30.4375 days. PFS (months) = (Date of Progression or Censoring - Date of Randomization + 1)/30.4375. |
| Secondary | Phase 2 Expansion: Overall Response Rate (ORR) Using RECIST 1.1 and irRECIST | Up to 1 year | ORR was defined as the crude percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) assessed using RECIST 1.1 and irRECIST. ORR calculated as: (number of participants with best overall response as CR or PR)/total number of participants. The overall response was determined locally by the investigator at each scheduled assessment. |
| Secondary | Phase 2 Expansion: Clinical Benefit Rate (CBR) Using RECIST 1.1 and irRECIST | Up to 1 year | CBR was estimated based on the crude percentage of participants in each treatment arm whose best overall response during the course of study treatment was CR, PR, or stable disease (SD) lasting for at least 24 weeks (measured from the date of randomization to the last date where SD was reported). |
| Secondary | Phase 2 Expansion: Overall Survival (OS) | Up to 5 years | OS was defined as the number of months from randomization to date of death from any cause. Participants who were alive or lost to follow-up as of a data analysis cutoff date were right-censored. One month was considered 30.4375 days. OS (months) = (Date of Death/Censoring - Date of Randomization + 1)/30.4375 |
| Secondary | Phase 2 Expansion: Duration of Response (DOR) | Up to 2 years | DOR was defined as the number of months from the date where a CR/PR (based on RECIST 1.1) or immune response CR (irCR)/immune response PR (irPR) was firstly observed, to the first date that recurrent or progressive disease was documented. |
| Secondary | Phase 2 Expansion: Time To Response (TTR) | Up to 2 years | TTR was defined for the subset of participants that achieved best overall response of confirmed CR/PR or confirmed irCR/irPR as the number of months from date of randomization to date of the initial documented response of CR/PR (based on RECIST 1.1) or irCR/irPR (based on irRECIST). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Participants Experiencing DLT | Up to 21 days after Cycle 1 Day 1 | A participant that experienced an adverse event (AE) meeting DLT criteria during Cycle 1 or who received the full dose of atezolizumab and all doses of entinostat during Cycle 1 without experiencing a DLT was considered DLT evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b: Determination of the RP2D | Up to 21 days after Cycle 1 Day 1 | Participants evaluable for DLTs. A participant that experienced an AE meeting DLT criteria during Cycle 1 or who received the full dose of atezolizumab and all doses of entinostat during Cycle 1 without experiencing a DLT was considered DLT evaluable. | milligram | NUMBER |
| PRIMARY | Phase 2 Expansion: Duration of Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to 1 year | Full Analysis Set (FAS): all participants who were randomized to study treatment, regardless of whether they actually received study medication. | months | MEDIAN |
| SECONDARY | Phase 2 Expansion: Duration of PFS Using Immune Response RECIST (irRECIST) | Up to 1 year | Full Analysis Set (FAS): all participants who were randomized to study treatment, regardless of whether they actually received study medication. | months | MEDIAN |
| SECONDARY | Phase 2 Expansion: Overall Response Rate (ORR) Using RECIST 1.1 and irRECIST | Up to 1 year | Full Analysis Set (FAS): all participants who were randomized to study treatment, regardless of whether they actually received study medication. | percentage of participants | NUMBER |
| SECONDARY | Phase 2 Expansion: Clinical Benefit Rate (CBR) Using RECIST 1.1 and irRECIST | Up to 1 year | Full Analysis Set (FAS): all participants who were randomized to study treatment, regardless of whether they actually received study medication. | percentage of participants | NUMBER |
| SECONDARY | Phase 2 Expansion: Overall Survival (OS) | Up to 5 years | Full Analysis Set (FAS): all participants who were randomized to study treatment, regardless of whether they actually received study medication. | months | MEDIAN |
| SECONDARY | Phase 2 Expansion: Duration of Response (DOR) | Up to 2 years | Data was not collected to estimate DOR using the prespecified Kaplan-Meier method for this outcome measure. | ||
| SECONDARY | Phase 2 Expansion: Time To Response (TTR) | Up to 2 years | Data was not collected to estimate TTR using the prespecified Kaplan-Meier method for this outcome measure. |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Participants Experiencing DLT | Phase 1b Dose Determination: Entinostat Plus Atezolizumab | 0 | Participants | ||
| Phase 1b: Determination of the RP2D | Phase 1b Dose Determination: Entinostat Plus Atezolizumab | 5 | milligram | ||
| Phase 2 Expansion: Duration of Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Phase 2 Expansion: Entinostat Plus Atezolizumab | 1.68 | 95% Confidence Interval 1.41 to 3.09 | months | |
| Phase 2 Expansion: Duration of Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Phase 2 Expansion: Placebo Plus Atezolizumab | 1.51 | 95% Confidence Interval 1.41 to 2.43 | months | |
| Phase 2 Expansion: Duration of PFS Using Immune Response RECIST (irRECIST) | Phase 2 Expansion: Entinostat Plus Atezolizumab | 1.68 | 95% Confidence Interval 1.45 to 3.81 | months | |
| Phase 2 Expansion: Duration of PFS Using Immune Response RECIST (irRECIST) | Phase 2 Expansion: Placebo Plus Atezolizumab | 1.54 | 95% Confidence Interval 1.41 to 2.83 | months | |
| Phase 2 Expansion: Overall Response Rate (ORR) Using RECIST 1.1 and irRECIST | Phase 2 Expansion: Entinostat Plus Atezolizumab | ORR per RECIST 1.1 | 12.5 | percentage of participants | |
| Phase 2 Expansion: Overall Response Rate (ORR) Using RECIST 1.1 and irRECIST | Phase 2 Expansion: Placebo Plus Atezolizumab | ORR per RECIST 1.1 | 2.4 | percentage of participants | |
| Phase 2 Expansion: Overall Response Rate (ORR) Using RECIST 1.1 and irRECIST | Phase 2 Expansion: Entinostat Plus Atezolizumab | ORR per irRECIST 1.1 | 12.5 | percentage of participants | |
| Phase 2 Expansion: Overall Response Rate (ORR) Using RECIST 1.1 and irRECIST | Phase 2 Expansion: Placebo Plus Atezolizumab | ORR per irRECIST 1.1 | 2.4 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b Dose Determination: Entinostat Plus Atezolizumab. | 8 | |
| Overall Study | STARTED | Phase 2 Expansion Phase: Entinostat Plus Atezolizumab | 40 | |
| Overall Study | STARTED | Phase 2 Expansion Phase: Placebo Plus Atezolizumab | 41 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | Phase 1b Dose Determination: Entinostat Plus Atezolizumab. | 8 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | Phase 2 Expansion Phase: Entinostat Plus Atezolizumab | 40 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | Phase 2 Expansion Phase: Placebo Plus Atezolizumab | 39 | |
| Overall Study | Dose-limiting Toxicity (DLT) Evaluable | Phase 1b Dose Determination: Entinostat Plus Atezolizumab. | 6 | |
| Overall Study | Dose-limiting Toxicity (DLT) Evaluable | Phase 2 Expansion Phase: Entinostat Plus Atezolizumab | 0 | |
| Overall Study | Dose-limiting Toxicity (DLT) Evaluable | Phase 2 Expansion Phase: Placebo Plus Atezolizumab | 0 | |
| Overall Study | COMPLETED | Phase 1b Dose Determination: Entinostat Plus Atezolizumab. | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events402
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 | Anaemia | Blood and lymphatic system disorders | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Expansion: Entinostat Plus Atezolizumab | 8 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Expansion: Placebo Plus Atezolizumab | 5 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Expansion: Entinostat Plus Atezolizumab | 0 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Expansion: Placebo Plus Atezolizumab | 0 | 39 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 0 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 2 Expansion: Entinostat Plus Atezolizumab | 6 | 40 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 2 Expansion: Placebo Plus Atezolizumab | 1 | 39 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 1 | 8 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 4 | 8 |
| Total, all-cause mortality | Phase 2 Expansion: Entinostat Plus Atezolizumab | 20 | 40 |
| Total, all-cause mortality | Phase 2 Expansion: Placebo Plus Atezolizumab | 21 | 41 |
| Total, other adverse events | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 8 | 8 |
| Total, other adverse events | Phase 2 Expansion: Entinostat Plus Atezolizumab | 34 | 40 |
| Total, other adverse events | Phase 2 Expansion: Placebo Plus Atezolizumab | 30 | 39 |
| Total, serious adverse events | Phase 1 Dose Determination Phase: Entinostat Plus Atezolizumab | 2 | 8 |
| Total, serious adverse events | Phase 2 Expansion: Entinostat Plus Atezolizumab | 18 | 40 |
| Total, serious adverse events | Phase 2 Expansion: Placebo Plus Atezolizumab | 14 | 39 |
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/NCT02708680
GET https://conductscience.org/api/trials/v1/NCT02708680/events?page=2