Arsenous Acid for Refractory Triple-Negative Breast Cancer

A Single-Arm, Two Stage, Phase II Study of Arsenous Acid Combined With Palliative Chemotherapy for Refractory Triple-Negative Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Arsenous Acid plus Chemotherapy

Detailed Description

The study is a Single-arm, two-stage, Phase II clinical trial. The main purposes of this study are to assess the efficacy and safety of arsenous acid in combination with palliative chemotherapy for refractory triple-negative breast cancer following multiple lines of treatment. Palliative chemotherapy regimen includes Eribulin, Gemcitabine, Utidelone and Vinorelbine, by the treatment of physician's choice (TPC). This study is designed based on Bayesian probability and divided into two stages. All patients will undergo tumor efficacy assessment every two cycles of treatment.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhong-yu Yuan, M.D.; Phone Number: China: +86 20 87343009; Email: yuanzhy@sysucc.org.cn
• Study Contact Backup: Name: Zhongyu Yuan, M.D.; Phone Number: +86-20-87342794; Email: yuanzhy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Zhong-yu Yuan, MD; Phone Number: 86-20-87343794; Email: yuanzhy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Understands and voluntarily signs the informed consent form.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
• Life expectancy greater than 3 months
• Histologically or cytologically confirmed metastatic invasive breast cancer, with negative for hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2). HR negative is defined as Immunohistochemistry (IHC) for estrogen receptor (ER) and/or progesterone receptor (PR) showing < 1% of tumor cells. HER2 negative is defined as IHC 0 or 1+, or IHC 2+ with a negative in-situ hybridization.
• Refractory to at least two prior standard therapeutic regimens for metastatic disease. 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. Additionally, 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. Recurrence within 12 months following TNBC adjuvant therapy is considered as first-line therapy.
• Eligible for one of the chemotherapy options listed as palliative chemotherapy (Eribulin, Gemcitabine, Utidelone, Vinorelbine) as per investigator assessment.
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). At least one lesion must not have received prior radiotherapy and should qualify as a baseline lesion according to RECIST 1.1 criteria, with a measurable longest diameter of ≥10 mm on CT or MRI (for lymph nodes, the short axis must be ≥15 mm). Patients with only bone metastases are eligible for enrollment, as are patients with stable brain metastases.
• 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.
• Premenopausal women can use medically acceptable methods of contraception during the study.
• Demonstrates good compliance.

Exclusion Criteria:

• Uncontrolled hypertension, persistent or active infections.
• Persistent toxicities from prior antitumor treatments (excluding alopecia) that have not improved to Grade ≤ 2 or baseline levels, such as hearing loss, neuropathy, or immune-related toxicities (hypothyroidism/hyperthyroidism, hyperglycemia, adrenal insufficiency, etc.).
• Tumor-related spinal cord compression or active brain metastases.
• Significant third-space fluid retention (e.g., ascites or pleural effusion) deemed by the investigator to be unsuitable for study participation.
• Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals.
• Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.
• Uncontrolled or significant cardiac disease, including myocardial infarction or unstable angina within the last six months, congestive heart failure, severe arrhythmias, or uncontrolled hypertension (resting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg).
• Suspected interstitial lung disease (ILD) or non-infectious pneumonia that cannot be ruled out and requires corticosteroid treatment.
• Active autoimmune diseases or inflammatory conditions (including inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, rheumatoid arthritis, uveitis, autoimmune non-infectious pneumonia, and autoimmune myocarditis).
• Concurrent treatment with any other antitumor therapies.
• Subjects deemed unlikely to comply with the study procedures and requirements by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arsenous Acid plus Chemotherapy; Arsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine	Drug: Arsenous Acid plus Chemotherapy; Arsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Progression-Free Survival (PFS) was defined as the time from enrollment until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first.	10 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): April 22, 2026
• Study Completion (Estimated): October 23, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: SYSUCC-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No