Trial · NCT02115282
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
NCT02115282, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2021-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic. Trials, record NCT02115282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02115282
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
- NCT number
- NCT02115282
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 608 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Interventions
- Biospecimen Collection, Computed Tomography, Entinostat, Exemestane, Goserelin, Goserelin Acetate, Magnetic Resonance Imaging, Placebo Administration, Quality-of-Life Assessment
- First posted
- 2014-04-16
- Last updated
- 2026-10-22
- Results first posted
- 2021-11-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | Progression-free survival (PFS) was defined to be time from randomization to the earliest documented disease progression as defined by the RECIST criteria, new primary breast cancer, or death without progression. Disease assessment was to continue until disease progression, even after non-protocol anti-cancer therapy was started. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of progression, regardless of whether non-protocol anti-cancer therapy was started or not. Disease progression was based on central review, and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. In addition, the appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used to estimate PFS rate. |
| Primary | Overall Survival (OS) | Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death | Overall survival (OS) was defined to be time from randomization to death from any cause. Cases who were still alive were censored at the date last known alive. |
| Secondary | Objective Response Rate (ORR) | Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | Objective response rate was defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses were evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s). |
| Secondary | Time-to-treatment Deterioration (TTD) | Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | Time-to-treatment deterioration (TTD) was defined as time from randomization to disease progression or death or worsening of symptoms, whichever occurred first. Disease progression was assessed per RECIST v1.1. Symptoms deterioration was measured by 6 items (GP1, GP2, GP4, GF7, B1, P2, scored 0-24) from the 8-item FACT-Breast Symptom Index (FBSI). Symptom deterioration was defined as two consecutive available decreases of at least 3 points from baseline using the 6-item FBSI in this trial, and the second visit time was used as the time of symptom deterioration in this case, unless it was the final score, for which one decrease was sufficient. Kaplan-Meier method was used to estimate the median TTD and TTD rate at a certain time point. Symptoms were assessed every cycle for the first six months after randomization, every two cycles between 6 months and 1 year. It then were assessed based on the same schedule for tumor assessments until disease progression as specified below. |
| Secondary | Lysine Acetylation Change in CD45 Blood Mononuclear Cells Between C1D1 and C1D15 and PFS in Patients on Arm A | Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | Peripheral blood samples (PBMCs) were collected prior to therapy and on Days 8 and 15 of cycle 1, for assessment of lysine acetylation, using an assay developed by the Trepel Laboratory, NCI/NIH. CD45 blood mononuclear cells were measured. Patients with lysine acetylation change of 1.5 folds or higher were compared to patients with lysine acetylation change of less than 1.5 folds. |
| Secondary | Patient-reported Health-related Quality of Life | Assessed at baseline and end of cycle 3 | Health-related quality of life (HRQL) was measured using Functional Assessment of Cancer Therapy - General (FACT-G). The primary endpoint for HRQL was the FACT-G Trial Outcome Index (TOI) which was an aggregate score of 5 items from the FACT-G-Physical subscale (GP2, GP3, GP4, GP6, and GP7) and 6 items from the FACT-G-Functional subscale (GF1, GF2, GF3, GF4, GF6, and GF7). All items were rated on a 5-point Likert scale from 0 to 4. FACT-G TOI subscale score was calculated based on the scoring manual, subscale score ranges from 0 to 44, and higher scores indicate better quality of life. The primary comparison of HRQL between treatment arms was based on the end of cycle 3 assessment. |
| Secondary | Patient-reported Diarrhea | Assessed at baseline and end of cycle 3 | Diarrhea was measured by Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea (FACIT-Diarrhea) subscale form, which had 11 items, all items were rated on a 5-point Likert scale from 0 to 4. FACIT-Diarrhea subscale score was calculated based on the scoring manual, subscale score ranges from 0 to 44, and higher score indicates less diarrhea. The primary comparison of patient-reported diarrhea between treatment arms was based on the end of cycle 3 assessment. |
| Secondary | Patient-reported Fatigue | Assessed at baseline and end of cycle 3 | Fatigue was measured by PROMIS Fatigue short form, it had 7 items and all items were rated on a 5-point Likert scale from 1 to 5. The PROMIS Fatigue total score and T score were calculated based on the scoring manual. The total score ranges from 7 to 35, the T score ranges from 29.4 to 83.2, higher scores indicate more fatigue. The PROMIS Fatigue T score was used for arm comparison. The primary comparison of patient-reported fatigue between treatment arms was based on the end of cycle 3 assessment. |
| Secondary | Patient-reported Nausea and Anorexia | Assessed at baseline and end of cycle 3 | Nausea and anorexia were measured by The Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-additional concerns, which had 12 items, all items were rated on a 5-point Likert scale from 0 to 4. FAACT-additional concerns subscale score was calculated based on scoring manual. Subscale score ranges from 0 to 48, and higher scores indicate less nausea and anorexia. The primary comparison of patient-reported nausea and anorexia between treatment arms was based on the end of cycle 3 assessment. |
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 | Progression-free Survival (PFS) | Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | The first 360 patients randomized to the trial (primary analysis population for the PFS endpoint) | months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death | All randomized patients (ie, intent-to-treat patients, primary analysis population for the OS endpoint) | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | All randomized patients (ie, the intent-to-treat population) | percentage of participants | NUMBER |
| SECONDARY | Time-to-treatment Deterioration (TTD) | Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | The first 360 patients randomized to the trial who received at least one dose of protocol therapy | months | MEDIAN |
| SECONDARY | Lysine Acetylation Change in CD45 Blood Mononuclear Cells Between C1D1 and C1D15 and PFS in Patients on Arm A | Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression | All patients who were randomized to arm A (exemestane +entinostat) and had lysine acetylation test results at both C1D1 and C1D15 | months | MEDIAN |
| SECONDARY | Patient-reported Health-related Quality of Life | Assessed at baseline and end of cycle 3 | All randomized patients who reported health-related quality of life data at end of cycle 3 assessment | units on a scale | MEAN |
| SECONDARY | Patient-reported Diarrhea | Assessed at baseline and end of cycle 3 | All randomized patients who reported FACIT-Diarrhea data at end of cycle 3 assessment | units on a scale | MEAN |
| SECONDARY | Patient-reported Fatigue | Assessed at baseline and end of cycle 3 | All randomized patients who reported PROMIS fatigue data at end of cycle 3 assessment | T-score | MEAN |
| SECONDARY | Patient-reported Nausea and Anorexia | Assessed at baseline and end of cycle 3 | All randomized patients who reported FAACT nausea and anorexia data at end of cycle 3 assessment | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Arm A (Exemestane, Entinostat) | 3.3 | 95% Confidence Interval 3.1 to 5.3 | months | |
| Progression-free Survival (PFS) | Arm B (Exemestane, Placebo) | 3.1 | 95% Confidence Interval 3.0 to 3.3 | months | |
| Overall Survival (OS) | Arm A (Exemestane, Entinostat) | 23.4 | 95% Confidence Interval 21.2 to 25.6 | months | |
| Overall Survival (OS) | Arm B (Exemestane, Placebo) | 21.7 | 95% Confidence Interval 19.3 to 27.1 | months | |
| Objective Response Rate (ORR) | Arm A (Exemestane, Entinostat) | 4.6 | 95% Confidence Interval 2.5 to 7.6 | percentage of participants | |
| Objective Response Rate (ORR) | Arm B (Exemestane, Placebo) | 4.3 | 95% Confidence Interval 2.3 to 7.2 | percentage of participants | |
| Time-to-treatment Deterioration (TTD) | Arm A (Exemestane, Entinostat) | 2.9 | 95% Confidence Interval 2.8 to 3.1 | months | |
| Time-to-treatment Deterioration (TTD) | Arm B (Exemestane, Placebo) | 2.9 | 95% Confidence Interval 2.8 to 3.0 | months | |
| Lysine Acetylation Change in CD45 Blood Mononuclear Cells Between C1D1 and C1D15 and PFS in Patients on Arm A | Arm A (Exemestane, Entinostat)- Lysine Acetylation Change>=1.5 Fold | 2.8 | 95% Confidence Interval 2.5 to 5.1 | months | |
| Lysine Acetylation Change in CD45 Blood Mononuclear Cells Between C1D1 and C1D15 and PFS in Patients on Arm A | Arm A (Exemestane, Entinostat)- Lysine Acetylation Change<1.5 Fold | 2.7 | 95% Confidence Interval 2.5 to 5.2 | months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Exemestane, Entinostat) | 305 | |
| Overall Study | STARTED | Arm B (Exemestane, Placebo) | 303 | |
| Overall Study | Eligible | Arm A (Exemestane, Entinostat) | 265 | |
| Overall Study | Eligible | Arm B (Exemestane, Placebo) | 257 | |
| Overall Study | Treated | Arm A (Exemestane, Entinostat) | 296 | |
| Overall Study | Treated | Arm B (Exemestane, Placebo) | 293 | |
| Overall Study | COMPLETED | Arm A (Exemestane, Entinostat) | 0 | |
| Overall Study | COMPLETED | Arm B (Exemestane, Placebo) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Exemestane, Entinostat) | 305 | |
| Overall Study | NOT COMPLETED | Arm B (Exemestane, Placebo) | 303 |
Source ClinicalTrials.gov
Adverse events210
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 | Anemia | Blood and lymphatic system disorders | Arm A (Exemestance, Entinostat) | 110 | 296 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Exemestance, Placebo) | 55 | 293 | |
| other | Edema limbs | General disorders | Arm A (Exemestance, Entinostat) | 54 | 296 | |
| other | Edema limbs | General disorders | Arm A (Exemestance, Placebo) | 16 | 293 | |
| other | Fatigue | General disorders | Arm A (Exemestance, Entinostat) | 167 | 296 | |
| other | Fatigue | General disorders | Arm A (Exemestance, Placebo) | 108 | 293 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Exemestance, Entinostat) | 37 | 296 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Exemestance, Placebo) | 21 | 293 | |
| other | Constipation | Gastrointestinal disorders | Arm A (Exemestance, Entinostat) | 36 | 296 | |
| other | Constipation | Gastrointestinal disorders | Arm A (Exemestance, Placebo) | 36 | 293 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Exemestance, Entinostat) | 209 | 305 |
| Total, all-cause mortality | Arm A (Exemestance, Placebo) | 203 | 303 |
| Total, other adverse events | Arm A (Exemestance, Entinostat) | 280 | 296 |
| Total, other adverse events | Arm A (Exemestance, Placebo) | 228 | 293 |
| Total, serious adverse events | Arm A (Exemestance, Entinostat) | 151 | 296 |
| Total, serious adverse events | Arm A (Exemestance, Placebo) | 47 | 293 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34357781 | DERIVED |
Source PubMed
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U24CA196172 | ECOG-ACRIN Biospecimen Bank to Support NCTN | JEWELL, SCOTT D; HAMILTON, STANLEY R. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2015 to 2025 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Exemestance, Entinostat) vs Arm A (Exemestance, Placebo): deaths from any cause | Trial comparisons |
| Arm A (Exemestance, Entinostat) vs Arm A (Exemestance, Placebo): serious adverse events | Trial comparisons |
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/NCT02115282
GET https://conductscience.org/api/trials/v1/NCT02115282/events?page=2