Clinical trial NCT02708680 (phase 1/phase 2, status: unknown status)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: entinostat, atezolizumab, placebo
SMILES: NC1=CC=CC=C1NC(=O)C1=CC=C(CNC(=O)OCC2=CN=CC=C2)C=C1, CCCNCC(O)COC1=C(C=CC=C1)C(=O)CCC1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Has histologically or cytologically confirmed triple negative breast carcinoma that is
             either metastatic (stage IV of the TNM classification) or locally recurrent and not
             amenable to local curative treatment.

          2. Evidence of measurable, locally recurrent or metastatic disease based on imaging
             studies within 28 days before the first dose of study drug.

          3. Has received at least 1, but no more than 2, prior lines of systemic therapy for
             locally recurrent and/or metastatic disease.

          4. If patient has a history of treated asymptomatic CNS metastases they are eligible,
             provided they meet all of the following criteria: Patient has measurable disease
             outside CNS; Patient does not have metastases to midbrain, pons, medulla or spinal
             cord; Patient is not on corticosteroids as therapy for CNS disease (anticonvulsants at
             a stable dose are allowed); Patient has not had whole-brain radiation within 6 weeks
             prior to study enrollment; Patient has stable CNS disease as demonstrated by at least
             4 weeks of stability between the last intervention scan and the study screening scan

          5. ECOG performance status of 0 or 1.

          6. Has acceptable, applicable laboratory parameters.

          7. Female subjects must not be pregnant; willing to use 2 methods of birth
             control/abstinence if applicable through 120 days after the last dose of study drug

          8. Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy
             to Grade <1 (except alopecia or neuropathy).

          9. Able to understand and give written informed consent and comply with study procedures.

        Exclusion Criteria:

          1. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
             of immunosuppressive therapy within 7 days prior to the first dose of study drug.

          2. Active autoimmune disease including active diverticulitis, symptomatic peptic ulcer
             disease, colitis, or inflammatory bowel disease that has required systemic treatment
             in past 2 years

          3. Previously treated with a PD-1/PD-L1-blocking antibody or a histone deacetylase
             inhibitor

          4. History or current evidence of any condition, therapy, or laboratory abnormality that
             might confound the results of the study, interfere with the patient's participation
             for the full duration of the study, or is not in the best interest of the patient to
             participate, in the opinion of the treating Investigator, including, but not limited
             to: History of immune deficiencies or autoimmune disease; Myocardial infarction or
             arterial thromboembolic events within 6 months prior to screening or severe or
             unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc
             interval > 470 msec; Uncontrolled hypertension or diabetes mellitus; Another known
             malignancy that is progressing or requires active treatment; Active infection
             requiring systemic therapy; Known active central nervous system (CNS) metastases
             and/or carcinomatous meningitis.

          5. Any contraindication to oral agents or significant nausea and vomiting, malabsorption,
             or significant small bowel resection that, in the opinion of the investigator, would
             preclude adequate absorption.

          6. Received a live vaccine within 30 days of the first dose of treatment.

          7. Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to enrollment or who
             has not recovered from AEs due to mAb agents administered more than 4 weeks earlier.

          8. Prior chemotherapy within 3 weeks, targeted small molecule therapy or radiation
             therapy within 2 weeks prior to enrollment, or who has not recovered (i.e., ≤Grade 1
             at enrollment) from AEs due to a previously administered agent.

          9. Received transfusion of blood products or administration of colony stimulating factors
             within 4 weeks prior to the first dose of treatment.

         10. Currently participating and receiving study therapy or has participated in a study of
             an investigational agent and received study therapy or used an investigational device
             within 4 weeks of the first dose of study drug.

         11. Currently receiving treatment with any other agent listed on the prohibited medication
             list

         12. If female, is pregnant, breastfeeding, or expecting to conceive starting with the
             screening visit through 120 days after the last dose of study drug.

         13. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

         14. Known active hepatitis B or hepatitis C

         15. Allergy to benzamide or inactive components of entinostat.

         16. History of allergies to any active or inactive ingredients of atezolizumab.

         17. Known psychiatric or substance abuse disorders that would interfere with cooperation
             with the requirements of the study.