EUCTR2009-012623-28-CZ进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Postmenopausal female patients
- •2. Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis, with current disease relapse or progression that occurred while receiving a non-steroidal aromatase inhibitor (anastrozole Arimidex®” or letrozole Femara®”), 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
- •b. Progressive disease on prior non-steroidal AI after at least 3 months of treatment in the advanced disease setting
- •3. 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 or PET-CT, according to local standard of care, within 4 weeks prior to study entry.
- •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.
- •4. Non-steroidal aromatase inhibitor (anastrozole Arimidex®” or letrozole Femara®”) treatment was the last systemic cancer therapy
- •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 receiving the first dose of study treatment
- •6. Patient may have had one prior chemotherapy in the metastatic setting as long as it was received before initiation of the most recent non-steroidal AI on which they progressed
- •7. ECOG performance status: 0 to 1 (Appendix 2)
- •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
排除标准
- •1. Discontinued non-steroidal aromatase inhibitor treatment for reasons other than relapse or progression
- •2. Received treatment with other cancer therapy(ies) following the last non-steroidal aromatase inhibitor therapy
- •3. Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting
- •4. Progressive disease after less than 3 months treatment with most recent non-steroidal AI for patients with metastatic disease
- •5. Rapidly progressive, life-threatening metastases, including any of the following:
- •a. Symptomatic lymphangitic metastases
- •b. Symptomatic CNS involvement or untreated or unstable CNS metastasis, or having taken steroids for such condition within 28 days of the first dose of study treatment
- •6. Previous treatment with entinostat or any other HDAC inhibitor including valproic acid
- •7. Previous treatment with exemestane (Aromasin®) and or fulvestrant (Faslodex ®)
- •8. Allergy to benzamides or inactive components of the study drug
- •9. A history of allergies to any active or inactive ingredients of exemestane
- •10. 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 (Appendix 3) 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.
- •11. Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
- •12. 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. Oral Bisphosphonates initiated within 7 days prior to study drug. See Section 6.6 for complete list.
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