A Ph 2, Randomized, Double-Blind, Multicenter Study of Exemestane +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal AI

Inclusion Criteria:

- Postmenopausal female patients

- Histologically or cytologically confirmed ER+ breast cancer

- Relapsed or progressed on prior treatment with AI

- Metastatic disease must be measurable

- Patients receiving palliative radiation at the non-target lesions must have a 2 week
wash out period following completion of the treatment prior to enrollment

- Patient may have had one prior chemotherapy as part of first line therapy as long as
it was received before initiation of prior AI

- ECOG performance status: 0 to 1

- Laboratory parameters: a)Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100.0 x 109/L; ANC ≥ 1.5
x 109/L without the use of hematopoietic growth factors b)Creatinine less than 2.5
times the upper limit of normal for the institution c)AST and ALT less than 2.5 times
the upper limit of normal for the institution

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

Exclusion Criteria:

- Relapse on treatment with non-steroidal AI after less than 12 months for patients in
the adjuvant setting

- Progressive disease after less than 3 months treatment with most recent AI for
patients with metastatic disease

- Rapidly progressive, life-threatening metastases

- Any palliative radiotherapy to the measurable lesion

- Previous treatment with SNDX-275 or any other HDAC inhibitor including valproic acid

- Allergy to benzamides or inactive components of the study drug

- A history of allergies to any active or inactive ingredients of exemestane

- Any concomitant medical condition that precludes adequate study treatment compliance

- Patient is currently enrolled in (or completed within 30 days before study drug
administration) another investigational drug study

- Patient is currently receiving treatment with valproic acid, Zolinza(vorinostat) or
any other HDAC inhibitor or DNA methyltransferase inhibitor or any systemic
anticancer treatment (with the exception of Lupron)