Oral CDB-4124 vs. Placebo in Stage 0-II Primary Breast Cancer

Inclusion Criteria

• Subjects must be females with a histological diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer clinical stage T0-3, N01 and be candidates for primary resection of this cancer; NOTE: subjects with bilateral cancer are eligible * Primary tumor stage T0-3 at the time of initial diagnosis and ipsilateral nodes must be N0-1 by clinical evaluation; staging is routinely based on the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and TNM Nomenclature for Breast Cancer from American Joint Committee on Cancer (AJCC) Cancer Staging Manual; all breast cancer patients routinely undergo axillary ultrasound to evaluate nodal involvement
• Subjects must have >= 0.5 cm of inflammatory breast cancer (IBC) on core (5 cores) * NOTE: If the core is less than 0.5 cm, the subjects may be considered for inclusion based on the pathologists’ review of biopsy slides
• Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Subjects must be able and willing to schedule surgical resection of their tumor 2 or more weeks following the start of the study agent
• Total bilirubin < 1.5 x upper limit of normal (ULN) (Gilbert's allowed 3 x ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN
• Alkaline phosphatase < 2.5 x ULN
• Blood urea nitrogen (BUN) < 2 x ULN
• Creatinine < 2 x ULN
• Subjects of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; OR * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Subjects of child bearing potential must have a negative urine pregnancy test within 5 days prior to first dose of the study drug
• Subjects must have the ability to understand and the willingness to sign a written informed consent; informed consent must be obtained prior to registration on the study
• Subjects who have been diagnosed with prior cancer at any site may participate as long as they have been off medical therapy for at least one year

Exclusion Criteria

• Subjects must not have received any other breast cancer-specific therapy for the current breast cancer diagnosis prior to registration
• Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
• Subjects must not have a history of thromboembolic disorder or cerebral vascular disease
• Subjects must not be pregnant or nursing
• Subjects must not be receiving any other investigational agents
• Subjects must not have allergies to any compounds similar to CDB-4124
• While participating, subjects must agree not to use soy supplements, over the counter estrogen supplements like Estroven, Chinese herbs, or other over-the-counter (OTC) herbal products
• Subjects must not have received medical therapy for any cancer within ONE year prior to registration
• Subjects must not have been diagnosed with estrogen receptor negative (ER-) AND progesterone receptor negative (PR-) breast cancer (patients must have either an ER or PR positive status)