OncoMatch/Clinical Trials/NCT05673200
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
Is NCT05673200 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Pembrolizumab and Decitabine and Cedazuridine for anatomic stage iii breast cancer ajcc v8.
Treatment: Decitabine and Cedazuridine · Paclitaxel · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression ≤ 10% (≤ 10%)
estrogen receptor [ER] =< 10%
Required: PR (PGR) expression ≤ 10% (≤ 10%)
progesterone receptor [PR] =< 10%
Required: HER2 (ERBB2) negative per ASCO/CAP guidelines (negative)
human epidermal growth factor receptor-2 [HER2]-negative per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines
Disease stage
Required: Stage III, IV (AJCC v8)
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma; Unresectable Triple-Negative Breast Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
ANC >= 1500/mm^3; Platelets >= 100,000/mm^3; Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (without pRBC transfusion within prior 14 days)
Kidney function
Creatinine clearance (CrCl) >= 30 mL/min (or GFR may be used)
Liver function
Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN for patients with total bilirubin > 1.5 × ULN; AST and ALT <= 3 x institutional ULN
Cardiac function
NYHA Functional Classification class II or better
ANC >= 1500/mm^3...Platelets >= 100,000/mm^3...Hemoglobin >= 9 g/dL or >= 5.6 mmol/L...Creatinine clearance (CrCl) >= 30 mL/min...Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN...AST and ALT <= 3 x institutional ULN...NYHA Functional Classification of class II or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- UC Irvine Health Cancer Center-Newport · Costa Mesa, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- Mayo Clinic in Florida · Jacksonville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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