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

About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast Cancer, Her2 -, ER+, CC-486 (ORAL AZACITIDINE), Metastatic Breast Cancer, Oral Azacitidine, Fulvestrant, Epigenetics
Eligibility 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)].
Sites / Locations
- Ironwood Cancer and Research Center
- Virginia G Piper Cancer Center
- Highlands Oncology Group
- Florida Cancer Specialists
- University of Kansas Hospital
- Henry Ford Health System
- Clinical Research Alliance
- Medical Oncology Associates
- Grand Hopital de Charleroi
- AZ Groeninge
- Clinique Sainte Elisabeth - Service d'Oncologie
- GasthuisZusters Antwerpen
- Centre Regional de lutte contre le cancer Paul Papin
- Institut Bergonie
- Hopital Pitie Salpetriere
- Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
- Universitatsklinikum Hamburg-Eppendorf / IVDP
- Hamatologisch Onkologische Praxis Eppendorf
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- TU München - Klinikum rechts der Isar
- Policlinico S. Orsola - Malpighi
- Ospedale San Raffaele S.r.l.
- Istituto Nazionale Dei Tumori
- IEO- Istituto Europeo di Oncologia
- Arcispedale Santa Maria Nuova
- Policlinico Umberto I
- Policlinico Universitario A Gemelli
- Azienda Ospedaliera Citta della Salute e della Scienza di Torino
- Hospital del Mar
- Hospital Universitario Vall D Hebron
- Complejo Universitario La Coruna
- Hospital General Gregorio Maranon
- Hospital Ramon y Cajal
- Hospital Clinico Universitario Virgen de La Victoria
- Hospital Virgen del Rocio
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
CC-486 and fulvestrant
Fulvestrant
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.
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.