18 and older, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Kaplan-Meier Estimate of Progression Free Survival (PFS)Primary· From the date of randomization of study drug to the date of the cut off date of 13 December 2016; follow-up for PFS was 21 months
Progression-free survival was defined as the duration from the date of randomization to the date of disease progression (DP) based on investigator's assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or death (from any cause), whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Group
Value
95% CI
CC-486 and Fulvestrant
5.49
2.07 – 8.25
Fulvestrant
5.46
3.58 – 7.36
Percentage of Participants Who Achieved a Confirmed Complete Response (CR) or Partial Response (PR) to Treatment (Objective Response Rate) Based On the Investigator AssessmentSecondary· Disease response was assessed every 8 weeks, for the first 24 weeks, then every 12 weeks until DP; from date of randomization of study drug to data cut-off date of 13 December 2016; follow-up for overall response was 21 months
Overall response rate was defined as the percentage of participants who achieved a confirmed complete response or partial response based on RECIST Version 1.1 criteria. RECIST criteria v 1.1 defined a CR as the disappearance of all target lesions and a PR with at least a 30% decrease in the sum of diameters of target lesions from baseline. The two-sided 95% exact binomial CI for each arm was estimated by the Clopper-Pearson method.
Group
Value
95% CI
CC-486 and Fulvestrant
8.3
2.32 – 19.98
Fulvestrant
2.0
0.05 – 10.85
Percentage of Participants Who Achieved a Confirmed CR, PR or Stable Disease (SD) for ≥ 24 Weeks (Clinical Benefit Rate) by Investigator AssessmentSecondary· Disease response was assessed every 8 weeks, for the first 24 weeks, then every 12 weeks until DP; from date of randomization of study drug to the data cut-off date of 13 December 2016; follow-up for clinical benefit response was 21 months
Percentage of participants with CR or PR or SD was defined per RECIST criteria v 1.1 as a CR that includes a disappearance of all target lesions, a PR was defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. The two-sided 95% exact binomial CI each arm was estimated by the Clopper-Pearson method.
Group
Value
95% CI
CC-486 and Fulvestrant
31.3
18.66 – 46.25
Fulvestrant
30.6
18.25 – 45.42
Kaplan Meier Estimate of Overall SurvivalSecondary· From the date of randomization of study drug to the data cut off date of 13 December 2016; participants were followed for overall survival for 21 months
Overall survival was defined as the time from the date of randomization to the date of death (from any cause). All participants who were lost to follow up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
Group
Value
95% CI
CC-486 and Fulvestrant
NA
13.7 – NA
Fulvestrant
NA
10.7 – NA
Kaplan Meier Estimate of Duration of Response (DoR)Secondary· From the date of randomization of study drug to the data cut-off of 13 December 2016; follow up for duration of response was 21 months
Duration of response was defined as the time from the first tumor assessment when the confirmed CR/PR criterion was first met to the date of disease progression, based on investigator's assessment following RECIST Version 1.1 criteria.
Group
Value
95% CI
CC-486 and Fulvestrant
NA
6.61 – NA
Fulvestrant
NA
NA – NA
Number of Participants With Treatment Emergent Adverse Events (TEAEs)Secondary· Randomization to 28 days after the last dose of IP; those AEs known at any time thereafter being related to IP; up to the last subject last visit of 21 November 2017; TEAE follow-up occurred up to 155 weeks and 2 days
Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on the participant's symptoms according to the Common Terminology Criteria for Adve
TEAE
Group
Value
95% CI
CC-486 and Fulvestrant
46
Fulvestrant
45
Grade 3 or 4 TEAE
Group
Value
95% CI
CC-486 and Fulvestrant
32
Fulvestrant
15
Grade 5 TEAE (Death)
Group
Value
95% CI
CC-486 and Fulvestrant
2
Fulvestrant
1
Serious TEAE
Group
Value
95% CI
CC-486 and Fulvestrant
10
Fulvestrant
7
TEAE Leading to Stopping of Any IP
Group
Value
95% CI
CC-486 and Fulvestrant
14
Fulvestrant
1
TEAE Leading to Dose Reduction of any IP
Group
Value
95% CI
CC-486 and Fulvestrant
19
Fulvestrant
0
TEAE Leading to Dose Interruption of any IP
Group
Value
95% CI
CC-486 and Fulvestrant
22
Fulvestrant
3
Treatment Related TEAE
Group
Value
95% CI
CC-486 and Fulvestrant
46
Fulvestrant
31
Adverse events — posted to ClinicalTrials.gov
Time frame: From randomization date to 28 days after the last dose of IP; those AEs known at any time thereafter being related to IP; up to last subject last visit date of 21 November 2017..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05413018 — An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myel
· Phase 2
· active not recruiting
NCT04887857 — A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants W
· Phase 1
· completed
NCT04722601 — A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma
· Phase 1, PHASE2
· terminated
NCT04778410 — Study of Magrolimab Combinations in Participants With Myeloid Malignancies
· Phase 2
· terminated
NCT04174196 — A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma
· Phase 2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 14 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02374099.