Actively Recruiting
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
32
Participants Needed
10
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of ASTX727 when given in combination with a usual approach of treatment with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The usual approach is defined as care most people get for this type of cancer. The usual approach for patients with metastatic triple negative breast cancer who are not in a study is chemotherapy with drugs like paclitaxel, carboplatin, cisplatin, eribulin, vinorelbine, capecitabine, gemcitabine, doxorubicin or cyclophosphamide. There is a protein called PD-L1 that helps regulate the body's immune system. For patients who have PD-L1+ tumors, immunotherapy (pembrolizumab) is usually added to paclitaxel or carboplatin/gemcitabine as initial treatment. For patients who have PD-L1-negative tumors, chemotherapy alone is used, without immunotherapy. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ASTX727 with usual treatment approach with paclitaxel and pembrolizumab may be able to shrink or stabilize the tumor for longer than the usual approach alone in patients with metastatic triple negative breast cancer.
CONDITIONS
Official Title
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed triple-negative breast cancer (ER and PR �310%, HER2-negative) that is metastatic or unresectable
- Age 18 years or older
- ECOG performance status 0, 1, or 2 (or Karnofsky �360%)
- Absolute neutrophil count �31500/mm^3 within 14 days prior to registration
- Platelet count �310,0000/mm^3 within 14 days prior to registration
- Hemoglobin �39 g/dL without recent transfusion within 14 days prior to registration
- Creatinine clearance �330 mL/min or GFR acceptable within 14 days prior to registration
- Total bilirubin �31.5 times upper limit of normal or direct bilirubin within normal limits if total bilirubin is higher
- AST and ALT �33 times institutional upper limit of normal within 14 days prior to registration
- For chronic hepatitis B, viral load must be undetectable on therapy if indicated
- For hepatitis C, must be cured or have undetectable viral load if on treatment
- Patients with treated brain metastases and no progression on follow-up imaging are eligible
- Prior malignancies allowed if not interfering with study assessments
- NYHA Functional Classification class II or better
- No live attenuated vaccines within 30 days prior to registration
- Prior peripheral neuropathy allowed if recovered to grade 1 or less
- HIV-infected patients on effective treatment with undetectable viral load within 6 months
- Received 0-3 prior lines of chemotherapy in metastatic setting
- Prior PD-1/PD-L1 antibody treatment allowed
- Willingness to provide tumor tissue samples as required
- Measurable disease per RECIST 1.1 for dose expansion cohort
- Agreement to use contraception during and after study participation
- Ability and willingness to provide informed consent
- Recovery from prior anti-cancer therapy adverse events except alopecia
- No blood transfusions or colony stimulating factors within 4 weeks prior to registration
You will not qualify if you...
- Immunodeficiency or use of high-dose systemic steroids or immunosuppressive therapy within 7 days prior to registration
- Additional progressing malignancy requiring active treatment
- Active autoimmune disease requiring systemic treatment within 2 years prior to registration
- Uncontrolled illness including lung disease or history of pneumonitis requiring steroids
- History of severe allergic reaction to paclitaxel or related drugs
- Receiving other investigational agents
- Allergic reactions to compounds similar to ASTX727, pembrolizumab, or paclitaxel
- Active tuberculosis
- Gastrointestinal disorders affecting oral drug absorption
- History of solid organ or bone marrow transplant
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, United States, 92627
Actively Recruiting
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Active, Not Recruiting
5
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
6
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
8
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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