OncoMatch/Clinical Trials/NCT06678048
Arsenous Acid for Refractory Triple-Negative Breast Cancer
Is NCT06678048 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Arsenous Acid plus Chemotherapy for breast cancer.
Treatment: Arsenous Acid plus Chemotherapy — The primary objective of this study is to assess the progression-free survival (PFS) and safety of arsenous acid in combination with palliative chemotherapy for refractory triple-negative breast cancer following multiple lines of treatment.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (<1% by IHC) (<1% by IHC)
HR negative is defined as Immunohistochemistry (IHC) for estrogen receptor (ER) and/or progesterone receptor (PR) showing < 1% of tumor cells.
Required: PR (PGR) negative (<1% by IHC) (<1% by IHC)
HR negative is defined as Immunohistochemistry (IHC) for estrogen receptor (ER) and/or progesterone receptor (PR) showing < 1% of tumor cells.
Required: HER2 (ERBB2) negative (IHC 0 or 1+, or IHC 2+ with negative ISH) (IHC 0 or 1+, or IHC 2+ with negative ISH)
HER2 negative is defined as IHC 0 or 1+, or IHC 2+ with a negative in-situ hybridization.
Allowed: PD-L1 (CD274) overexpression (CPS ≥10)
For TNBC patients with a programmed death-ligand 1 (PD-L1/22C3) positive result (combined positive score, CPS ) ≥10, eligibility requires prior treatment with chemotherapy combined with PD-1.
Allowed: BRCA1 germline mutation
TNBC patients with a known germline breast cancer susceptibility gene (BRCA) mutation, who are assessed to be unsuitable for or unable to receive poly (ADP-ribose) polymerase (PARP) inhibitor therapy by the physician, also qualify for the study.
Allowed: BRCA2 germline mutation
TNBC patients with a known germline breast cancer susceptibility gene (BRCA) mutation, who are assessed to be unsuitable for or unable to receive poly (ADP-ribose) polymerase (PARP) inhibitor therapy by the physician, also qualify for the study.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: cytotoxic chemotherapy — metastatic
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L.
Liver function
Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN). Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN, except in cases of Hepatitis B Virus (HBV). For patients with liver metastases, ALT and AST ≤ 5 × ULN.
Patients must have adequate bone marrow reserves and normal organ function, as defined by the following criteria: Hemoglobin ≥ 9.0 g/dL. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN). Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN, except in cases of Hepatitis B Virus (HBV). For patients with liver metastases, ALT and AST ≤ 5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06678048 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cytotoxic chemotherapy.
Does this trial require ESR1?
Yes, ESR1 negative (<1% by IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative (<1% by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0 or 1+, or IHC 2+ with negative ISH) is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages