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Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer
Phase 2 trial testing entinostat in Breast Cancer in 130 participants. Completed in 26 November 2012.
| Lead sponsor | Syndax Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 13 June 2008 |
| Primary completion | 29 January 2011 |
| Estimated completion | 26 November 2012 |
| Sites | 38 locations across Russia, Hungary, Canada, United States, Czechia |
Syndax Pharmaceuticals — full company profile →
18 and older, female only, with Breast Cancer or Estrogen Receptor-Positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Exemestane 25 mg + Placebo | 2.27 | 1.81 – 3.68 |
| Exemestane 25 mg + Entinostat 5 mg | 4.28 | 3.26 – 5.36 |
ORR is defined as the percentage of participants with response during treatment classified as complete response (CR) or partial response (PR), 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.
| Group | Value | 95% CI |
|---|---|---|
| Exemestane 25 mg + Placebo | 4.6 | 1.0 – 12.7 |
| Exemestane 25 mg + Entinostat 5 mg | 4.7 | 1.0 – 13.1 |
CBR is defined as the percentage of participants with overall response (CR + PR) plus stable disease (SD) for 6 months 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 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 PD, taking as reference the smallest sum LD since the treatment started.
| Group | Value | 95% CI |
|---|---|---|
| Exemestane 25 mg + Placebo | 25.8 | 15.8 – 38.0 |
| Exemestane 25 mg + Entinostat 5 mg | 26.6 | 16.3 – 39.1 |
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. A TEAE is an AE that starts after the administration of stud
| Group | Value | 95% CI |
|---|---|---|
| Exemestane 25 mg + Placebo | 56 | |
| Exemestane 25 mg + Entinostat 5 mg | 60 |
| Group | Value | 95% CI |
|---|---|---|
| Exemestane 25 mg + Placebo | 8 | |
| Exemestane 25 mg + Entinostat 5 mg | 10 |
OS was defined as the number of months elapsed between the date of randomization and the date of death (whatever the cause).
| Group | Value | 95% CI |
|---|---|---|
| Exemestane 25 mg + Placebo (EP) | 19.84 | 17.04 – 26.71 |
| Exemestane 25 mg + Entinostat 5 mg (EE) | 28.13 | 21.15 – NA |
Time frame: First dose to within 30 days of last dose of study drug (Up to approximately 2 Years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Exemestane 25 mg + Placebo | Exemestane 25 mg + Entinos… |
|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Anemia group | Blood and lymphatic system disorders | — | — |
| Lobar pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Atrial tachycardia | Cardiac disorders | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Enterocutaneous fistula | Gastrointestinal disorders | — | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Leukopenia group | Blood and lymphatic system disorders | — | — |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Oesophagitis | Gastrointestinal disorders | — | — |
| Overdose | Injury, poisoning and procedural complications | — | — |
| Pancreatic mass | Gastrointestinal disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Procedural nausea | Injury, poisoning and procedural complications | — | — |
| Pyrexia | General disorders | — | — |
| Radiation pneumonitis | Injury, poisoning and procedural complications | — | — |
| Sepsis | Infections and infestations | — | — |
| Thrombocytopenia group | Blood and lymphatic system disorders | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Exemestane 25 mg + Placebo | Exemestane 25 mg + Entinos… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Neutropenia group | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Weight decreased | Investigations | — | — |
| Anemia group | Blood and lymphatic system disorders | — | — |
| Thrombocytopenia group | Blood and lymphatic system disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Leukopenia group | Blood and lymphatic system disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Vascular disorders | Vascular disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Insomnia | Nervous system disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Hot flush | General disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Electrocardiogram QT prolonged | Investigations | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Pyrexia | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Chills | General disorders | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — |
Most-reported serious reactions: Pneumonia, Anemia group, Lobar pneumonia, Asthenia, Atrial tachycardia, Chronic obstructive pulmonary disease, Constipation, Deep vein thrombosis.
Data from ClinicalTrials.gov NCT00676663 adverse events section.
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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