A Phase 2, Multicenter, Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women with ER+ Breast Cancer Whose Disease is Progressing

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 28

Inclusion Criteria

1. Postmenopausal female patients.
2. Histolologically or cytologically confirmed ER+ breast cancer.
3. Progressive disease (PD) after at least 3 months on treatment with a 3rd generation AI in the advanced disease setting as measured by RECIST criteria; progression documented CT-scan.
4. At least 1 measurable lesion = 20 mm by conventional techniques or = 10 mm by spiral CT scan with the last imaging performed within 4 weeks prior to study entry.
5. ECOG 0-1.
6. Laboratory parameters:
a) Hemoglobin = 9.0 g/dL; platelets = 100 x109/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.
7. Able to understand and give written informed consent and comply with study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Discontinuation of AI therapy prior to study entry.
2. Less than 3 months treatment with most recent AI.
3. Rapidly progressive, life-threatening metastases, including any of the following:
a) Symptomatic lymphangitic metastases.
b) Patients with known active brain or leptomeningeal involvement.
4. More than one prior chemotherapy for metastatic disease.
5. Any chemotherapy within 3 months prior to study.
6. Radiotherapy to measurable lesion within 2 months prior to study.
7. Bisphosphonates initiated within 4 weeks prior to study start.
8. Allergy to benzamides or inactive components of study drug.
9. Previous treatment with SNDX-275 or any other HDAC inhibitor including valproic acid.
10. Patient is currently receiving treatment with any agent listed on the prohibited medication list such as valproic acid, other systemic cancer agents (with the exception of Lupron or other approved luteinising-hormone releasing hormone (LHRH) agonists such as godserelin or leuproelin. See Section 6.6 for complete list.
11. Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator:
a) Examples: unstable angina, uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection, another malignancy within 5 years.
12. Patient currently is enrolled in (or completed within 30 days before study drug administration) another investigational drug study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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