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Spokane, Washington 99208

  • Breast Neoplasms

Purpose:

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).


Study summary:

This is a Phase 2, open-label, two-arm study assessing the efficacy and safety of the combination of fulvestrant with CC-486 in subjects with ER+, HER2- metastatic breast cancer who have progressed after prior AI. Approximately 92 participants will be enrolled and assigned randomly in a 1:1 ratio to one of two treatment arms: - Arm A: CC-486 300 mg and fulvestrant 500 mg: 46 subjects - Arm B: Fulvestrant 500 mg: 46 subjects Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle. Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles. Safety will be evaluated by an independent data monitoring committee (DMC) after a total of approximately 32 subjects have completed at least 1 treatment cycle.


Criteria:

Inclusion Criteria: - Subject is female ≥ 18 years of age (at the time of signing the informed consent form) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy. - Subject is considered postmenopausal - Subject has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory (based on most recently analyzed biopsy). - Subject has human epidermal growth factor receptor 2 negative (HER2-) breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. - Subject had disease refractory to an AI - Subject has an Eastern Cooperative Oncology Group ( ECOG) performance status of 0-1. - Subject has radiological documented measurable disease (ie, at least one measureable lesion as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1). - If no measurable disease is present, then at least one predominantly lytic bone lesion must be present - Subject has adequate organ function. - Subject has adequate bone marrow function. Exclusion Criteria: - Subject has received > 1 prior line of chemotherapy in the metastatic setting - Subject has received any chemotherapy within 21 days prior to randomization. - Subject has received prior treatment with fulvestrant. - Subject has been previously treated with azacitidine (any formulation), decitabine, or any other hypomethylating agent. - Subject has a history of, or current symptomatic brain metastasis. - Subject has severe renal impairment (creatinine clearance < 30 ml/min). - Subject has an impaired ability to swallow oral medication. - Subject has a contraindication to receiving IM injections (eg, bleeding disorders, anticoagulant use). - Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure. - Subject is a female of Childbearing Potential [defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oopherectomy (the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time during the preceding 12 consecutive months)].


Study is Available At:


Original ID:

CC-486-BRSTM-001


NCT ID:

NCT02374099


Secondary ID:


Study Acronym:


Brief Title:

Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant


Official Title:

A Phase 2, Randomized, Open-label, Two-arm 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 ER+, HER2- Metastatic Breast Cancer Who Have P


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Celgene


Oversight Authority:

  • Belgium: Federal Agency for Medicinal Products and Health Products
  • Germany: Ethics Commission
  • Germany: Federal Institute for Drugs and Medical Devices
  • Italy: Ethics Committee
  • Italy: The Italian Medicines Agency
  • Spain: Ethics Committee
  • Spain: Spanish Agency of Medicines
  • United States: Federal Government
  • United States: Food and Drug Administration
  • United States: Institutional Review Board
  • France: Agence Nationale de Sécurité du Médicament et des produits de santé
  • Spain: Agencia Española de Medicamentos y Productos Sanitarios
  • Germany: Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

97


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ileana Elias, MD
Study Director
Celgene

Study Dates

Start Date:March 13, 2015
Completion Date:November 21, 2017
Completion Type:Actual
Primary Completion Date:December 13, 2016
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 12, 2018
First Received Date:January 22, 2015
First Results Date:November 15, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Kaplan-Meier Estimate of Progression Free Survival (PFS)
Time Frame:From the date of randomization of study drug to the date of the cut off date of 13 December 2016; fo
Safety Issues:False
Description: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 caus
Outcome Type:Secondary Outcome
Measure:Percentage of Participants Who Achieved a Confirmed Complete Response (CR) or Partial Response (PR) to Treatment (Objective Response Rate) Based On the Investigator Assessment
Time Frame:Disease response was assessed every 8 weeks, for the first 24 weeks, then every 12 weeks until DP; f
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Percentage of Participants Who Achieved a Confirmed CR, PR or Stable Disease (SD) for ≥ 24 Weeks (Clinical Benefit Rate) by Investigator Assessment
Time Frame:Disease response was assessed every 8 weeks, for the first 24 weeks, then every 12 weeks until DP; f
Safety Issues:False
Description: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 an
Outcome Type:Secondary Outcome
Measure:Kaplan Meier Estimate of Overall Survival
Time Frame:From the date of randomization of study drug to the data cut off date of 13 December 2016; participa
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Kaplan Meier Estimate of Duration of Response (DoR)
Time Frame:From the date of randomization of study drug to the data cut-off of 13 December 2016; follow up for
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame:Randomization to 28 days after the last dose of IP; those AEs known at any time thereafter being rel
Safety Issues:False
Description: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-threate

Study Interventions

Intervention Type:Drug
Name:CC-486
Description:Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle
Arm Name:CC-486 and fulvestrant
Other Name:Oral Azacitidine
Intervention Type:Drug
Name:Fulvestrant
Description:Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Arm Name:CC-486 and fulvestrant
Other Name:Faslodex

Study Arms

Study Arm Type:Experimental
Arm Name:CC-486 and fulvestrant
Description:CC-486 300 mg by mouth (PO) daily on days 1-21 of each 28 day cycle and fulvestrant 500mg by intramuscular (IM) injection on Days 1 and 15 of cycle 1 and day 1 of each subsequent cycle every 28 days.
Study Arm Type:Experimental
Arm Name:Fulvestrant
Description:Fulvestrant will be administered by intramuscular injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Celgene

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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