Recurrent Breast Carcinoma Clinical Trial
Official title:
Phase II Study of Azacitidine and Entinostat (SNDX-275) in Patients With Advanced Breast Cancer
This phase II trial studies how well giving azacitidine and entinostat work in treating patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.
PRIMARY OBJECTIVES: I. To evaluate objective response rate by Response Evaluation Criteria In Solid Tumors (RECIST) criteria of the combination of azacitidine (5-AZA) and entinostat in women with advanced breast cancer; triple-negative and hormone-refractory. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of the combination of 5-AZA and entinostat in women with advanced breast cancer. II. To determine progression-free survival, overall survival, and clinical benefit rate of the combination of 5-AZA and entinostat. TERTIARY OBJECTIVES: I. To collect safety and toxicity data as well as the feasibility and response rate where hormonal therapy is added to the combination under investigation at the time of progressive disease. (Exploratory) II. To determine the pharmacokinetic profile of 5-AZA (full profile) and entinostat (trough concentrations) in patients with advanced breast cancer. (Exploratory) III. To assess serum cytidine deaminase pharmacogenetics and phenotypic activity as a potential biomarker of response to 5-AZA. (Exploratory) IV. To evaluate baseline and change in candidate gene re-expression (e.g., estrogen receptor [ER] alpha, retinoic acid receptor [RAR] beta) in malignant tissue obtained from selected patients through fine-needle aspiration (FNA) and core biopsy, prior to and following combination therapy. (Exploratory) V. To evaluate baseline and change in gene methylation silencing in circulating deoxyribonucleic acid (DNA) obtained prior to and following combination therapy. (Exploratory) VI. To evaluate baseline and change in gene methylation in malignant tissue obtained through FNA and core biopsy. (Exploratory) OUTLINE: This is a multicenter study. Patients receive azacitidine subcutaneously (SC) on days 1-5 and 8-10, and entinostat orally (PO) on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring. After completion of study therapy, patients are followed up every 3-6 months for up to 3 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04052555 -
Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04521764 -
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
|
Phase 1 | |
| Completed |
NCT00100750 -
Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Suspended |
NCT03737695 -
Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
|
||
| Active, not recruiting |
NCT02595905 -
Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases
|
Phase 2 | |
| Terminated |
NCT02149173 -
F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy
|
N/A | |
| Completed |
NCT00390455 -
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
|
Phase 3 | |
| Recruiting |
NCT03213041 -
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT04529044 -
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
|
Phase 2 | |
| Completed |
NCT00699491 -
Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03364348 -
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
|
Phase 1 | |
| Terminated |
NCT01149356 -
RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer
|
Phase 1 | |
| Completed |
NCT01964924 -
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer
|
Phase 2 | |
| Completed |
NCT00785291 -
Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
|
Phase 3 | |
| Terminated |
NCT02370264 -
Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer
|
N/A | |
| Terminated |
NCT01071564 -
RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
| Terminated |
NCT00998738 -
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT00520975 -
First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU
|
Phase 3 | |
| Completed |
NCT01251874 -
Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03281902 -
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
|