A Phase 2, Randomized, Double-Blind, Multicenter Study of Exemestane With and Without SNDX-275 in Postmenopausal Women with Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer, Progressing on Treatment with a Non-Steroidal Aromatase Inhibitor

• Conditions: ER+ breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2009-012623-28-HU
• Lead Sponsor: Syndax Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-10
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

1) Postmenopausal female patients
2) Histologically or cytologically confirmed ER+ breast cancer
3) Relapsed or progressed on prior treatment with non-steroidal AI, meeting either of the following criteria:
a) Relapse on non-steroidal AI given as adjuvant AI after at least 12 months treatment with the AI (stratum 1)
OR
b) Progressive disease on prior non-steroidal AI after at least 3 months of treatment in the advanced disease setting (stratum 2)
4) Evidence of metastatic disease based on imaging studies (bone scan, CT, MRI):
a) Patients with bone only metastases are eligible provided there is a positive bone scan confirmed with MRI within 4 weeks prior to study entry.
OR
b) 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. If there is only one measurable lesion and it is located in previously irradiated field, it must have demonstrated progression according to RECIST criteria.
5) 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
6) Patient may have had one prior chemotherapy as first line therapy for metastatic disease as long as it was received before initiation of prior non-steroidal AI
7) ECOG performance status: 0 to 1
8) 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
9) 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) Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting
2) Progressive disease after less than 3 months treatment with most recent AI for patients with metastatic disease
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) Previous treatment with entinostat or any other HDAC inhibitor including valproic acid
5) Allergy to benzamides or inactive components of the study drug
6) A history of allergies to any active or inactive ingredients of exemestane
7) Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator
a) Myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease and a QTc interval > 0.47 second.
b) Uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection
c) Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN / cervical carcinoma in situ] or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
8) Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
9) 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 approved luteinising-hormone releasing hormone (LHRH) agonists such as goserelin or leuprolide. Bisphosphonates initiated within 7 days prior to study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified