Spots Global Cancer Trial Database for Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
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Trial Identification
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 Progressed on an Aromatase Inhibitor
Study ID: NCT02374099
Conditions
Study Description
Brief Summary: 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).
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Center, Chandler, Arizona, United States
Virginia G Piper Cancer Center, Scottsdale, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
University of Kansas Hospital, Westwood, Kansas, United States
Henry Ford Health System, Detroit, Michigan, United States
Clinical Research Alliance, New York, New York, United States
Medical Oncology Associates, Spokane, Washington, United States
Grand Hopital de Charleroi, Charleroi, , Belgium
AZ Groeninge, Kortrijk, , Belgium
Clinique Sainte Elisabeth - Service d'Oncologie, Namur, , Belgium
GasthuisZusters Antwerpen, Wilrijk, , Belgium
Centre Regional de lutte contre le cancer Paul Papin, Angers, , France
Institut Bergonie, Borddeaux Cedex, , France
Hopital Pitie Salpetriere, Paris, , France
Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique, Saint Herblain, , France
Universitatsklinikum Hamburg-Eppendorf / IVDP, Hamburg, , Germany
Hamatologisch Onkologische Praxis Eppendorf, Hamburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
TU München - Klinikum rechts der Isar, München, , Germany
Policlinico S. Orsola - Malpighi, Bologna, , Italy
Ospedale San Raffaele S.r.l., Milano, , Italy
Istituto Nazionale Dei Tumori, Milano, , Italy
IEO- Istituto Europeo di Oncologia, Milano, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Policlinico Umberto I, Roma, , Italy
Policlinico Universitario A Gemelli, Roma, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Piemonte, , Italy
Hospital del Mar, Barcelona, , Spain
Hospital Universitario Vall D Hebron, Barcelona, , Spain
Complejo Universitario La Coruna, La Coruna, , Spain
Hospital General Gregorio Maranon, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Clinico Universitario Virgen de La Victoria, Malaga, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Contact Details
Name: Ileana Elias, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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