Breast CancerPhase 2NCT06678048
Arsenous Acid for Refractory Triple-Negative Breast Cancer
A Phase 2 study testing Arsenous Acid plus Chemotherapy in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arsenous Acid plus Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 23 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhong-yu Yuan, MD, 86-20-87343794, yuanzhy@sysucc.org.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Arsenous Acid plus Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenous Acid plus ChemotherapyDrug
Arsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine
| Study group | Role | What they receive |
|---|---|---|
| Arsenous Acid plus Chemotherapy | Experimental | Arsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine Receives: Drug: Arsenous Acid plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start23 Oct 2024
- Primary completion22 Apr 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678048
- Sponsor's protocol ID
- SYSUCC-036
- Status last verified
- Jun 2025
- First submitted
- 5 Nov 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Two Stage, Phase II Study of Arsenous Acid Combined With Palliative Chemotherapy for Refractory Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06678048
- Acronym / sponsor ID
- SYSUCC-036
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arsenous Acid plus Chemotherapy | Experimental | Drug: Arsenous Acid plus ChemotherapyArsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arsenous Acid plus ChemotherapyArsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine | Drug | Arsenous Acid plus Chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 10 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arsenous Acid plus Chemotherapy in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhong-yu Yuan, M.D. (China: +86 20 87343009, yuanzhy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.