A Phase 2 interventional study of Entinostat and Aromatase Inhibitor (AI) Therapy in ER+ Breast Cancer, sponsored by Syndax Pharmaceuticals. Completed at 6 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Syndax Pharmaceuticals · Phase 2, Interventional, and Treatment
The addition of entinostat to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor.
It is hypothesized that entinostat with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an acceptable safety profile.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 27 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Syndax Pharmaceuticals is the lead sponsor of 30 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
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Laboratory parameters:
Exclusion Criteria:
Rapidly progressive, life-threatening metastases, including any of the following:
Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator:
Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.
Drug: Entinostat · Drug: Aromatase Inhibitor (AI) Therapy
Entinostat 5 mg PO every week
Also known as: SNDX-275
AI therapy at labeled dose and schedule as prescribed in clinical practice. AI therapies include: Arimidex® (anastrozole) 1 mg/day by mouth (PO), Fermara® (letrozole) 2.5 mg/day PO , Aromasin® (exemestane) 25 mg/day PO.
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants who achieved complete response (CR) or partial response (PR) or stable disease (SD) for 6 months as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started.
Time frame: 6 months
Progression-Free Survival (PFS)
PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.
Time frame: Up to 6, 28-day cycles
Objective Response Rate (ORR) During the First 6 Cycles of Study Treatment
ORR is defined as the percentage of participants with response during treatment classified as CR or PR, as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 6, 28-day cycles
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs.
Time frame: Up to 6, 28-day cycles + 30 days
Participants took part in the study at 8 investigative sites in the United Kingdom and Ireland from 1 October 2008 to 24 November 2009.
| Milestone | Entinostat 5 mg + AI |
|---|---|
| Started | 27 |
| Completed | 0 |
| Not completed | 27 |
| Withdrew: Disease progression | 17 |
| Withdrew: Adverse event | 9 |
| Withdrew: Reason not specified | 1 |
CBR is defined as the percentage of participants who achieved complete response (CR) or partial response (PR) or stable disease (SD) for 6 months as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started.
| percentage of participants | Entinostat 5 mg + AI |
|---|---|
| Clinical Benefit Rate (CBR) | 15.4 (4.4 to 34.9) |
PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.
| months | Entinostat 5 mg + AI |
|---|---|
| Progression-Free Survival (PFS) | 3.9 (1.9 to 5.6) |
ORR is defined as the percentage of participants with response during treatment classified as CR or PR, as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
| percentage of participants | Entinostat 5 mg + AI |
|---|---|
| Objective Response Rate (ORR) During the First 6 Cycles of Study Treatment | 3.9 (0.1 to 19.6) |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs.
| Participants | Entinostat 5 mg + AI |
|---|---|
| Number of Participants With Adverse Events (AEs) | 27 |
Collected over Up to 6, 28-day cycles + 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Entinostat 5 mg + AI | — | 15/27 (55.6%) | 27/27 (100%) |
| Event | Entinostat 5 mg + AI |
|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/27 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/27 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/27 |
| PancytopeniaBlood and lymphatic system disorders | 1/27 |
| Cardiac failure congestiveCardiac disorders | 1/27 |
| Pericardial effusionCardiac disorders | 1/27 |
| Adverse drug reactionGeneral disorders | 1/27 |
| Respiratory tract infectionInfections and infestations | 1/27 |
| Hip fractureInjury, poisoning and procedural complications | 1/27 |
| DehydrationMetabolism and nutrition disorders | 1/27 |
| Event | Entinostat 5 mg + AI |
|---|---|
| FatigueGeneral disorders | 15/27 |
| NauseaGastrointestinal disorders | 15/27 |
| DiarrhoeaGastrointestinal disorders | 13/27 |
| Weight decreasedInvestigations | 11/27 |
| Oedema peripheralGeneral disorders | 10/27 |
| LethargyNervous system disorders | 8/27 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/27 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 7/27 |
| VomitingGastrointestinal disorders | 7/27 |
| PainGeneral disorders | 6/27 |
Full Analysis Set consisted of all eligible patients who signed informed consent.
| Age, Continuous(years) | Entinostat 5 mg + AI |
|---|---|
| Mean | 68 ± 7.0 |
| Age, Customized(Participants) | Entinostat 5 mg + AI |
|---|---|
| 45 to 64 years | 7 |
| 65 to 74 years | 15 |
| 75 years and older | 5 |
| Sex: Female, Male(Participants) | Entinostat 5 mg + AI |
|---|---|
| Female | 27 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Entinostat 5 mg + AI |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 26 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Entinostat 5 mg + AI |
|---|---|
| Ireland | 9 |
| United Kingdom | 18 |
| Eastern Cooperative Oncology Group (ECOG) Status(Participants) | Entinostat 5 mg + AI |
|---|---|
| Score=0 | 9 |
| Score=1 | 18 |
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Entinostat