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

Stopped early · Phase 2

Conditions studied: Breast Neoplasms

In brief

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).

Key facts

Study ID: NCT02374099
Run by: Celgene
People needed: 97
Starts: 2015-03-13
Expected to finish: 2017-11-21
Last updated by the study team: 2018-12-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)].

Where it is running

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. — Milan, Italy
Istituto Nazionale Dei Tumori — Milan, Italy
IEO- Istituto Europeo di Oncologia — Milan, Italy
Arcispedale Santa Maria Nuova — Reggio Emilia, Italy

Full record on ClinicalTrials.gov

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