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Advanced Breast CancerPhase 2NCT06354114

A Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011

A Phase 2 study testing SYHX2011 in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
SYHX2011
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
Apr 2024to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Voluntarily sign the written informed consent and willing to cooperate with the research according to the requirements of the plan.
  • 2.Breast cancer confirmed by histology or cytology and meeting the following conditions:
  • According to the breast cancer diagnosis and treatment guidelines (2022) of the Chinese Society of Clinical Oncology (CSCO), the breast cancer patients who are suitable for anti-tumor treatment with paclitaxel for injection (albumin-bound) alone judged by the investigators.
  • According to RECIST 1.1 standard, there is at least one measurable lesion. For the lesions that have been treated with radiotherapy in the past, only if the disease progression is clear after radiotherapy, then the lesions can be included as the measurable lesions.
  • 3. Age ≥ 18 years.
  • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before the first administration.
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  • 5. Expected survival time ≥3 months.
  • 6. Normal function of main organs within 7 days before the first administration [no blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or other medical support treatment within 14 days before the first administration], meeting the following criteria:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT)≥ 100 × 10^9/L; Hemoglobin (Hb) ≥ 90 g/L.
  • AST \& ALT ≤ 10 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance ≥ 30 mL/min.
  • Activated partial thrombin time (APTT) /Prothrombin time (PT)/International standardized ratio (INR)≤1.5 × ULN.
  • 7. The patients with fertility agreed to use reliable contraceptive measures (such as intrauterine device [IUD], contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum pregnancy test of women of childbearing age is negative within 7 days before the study enrollment.

Who cannot join

  • 1. History of severe allergy or major hypersensitivity to paclitaxel or human serum albumin (NCI-CTCAE Version 5.0, ≥ Level 3).
  • 2. The toxicity of previous anti-tumor treatment has not recovered (NCI-CTC AE 5.0, >Level 1); Skin reaction or other hypersensitivity caused by any reason does not return to normal.
  • 3. Patients with symptomatic brain metastasis or meningeal metastasis, or there is any evidence that shows uncontrolled brain metastasis or meningeal metastasis.
  • 4. History of malignant tumors other than breast cancer within 5 years before the first administration, except for tumors that have recovered after treatment, such as carcinoma in situ, basal cell carcinoma, etc.
  • 5. There are any of the following concomitant diseases:
  • Serious or uncontrolled cardiovascular diseases: such as chronic congestive heart failure of grade Ⅱ or above (NYHA standard), uncontrolled hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>90 mmHg after regular treatment), etc.
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  • There are clearly identified neurological diseases (such as epilepsy, dementia, etc.) and ≥ grade 3 peripheral neuropathy.
  • Serious respiratory diseases, such as asthma requiring glucocorticoid drugs, chronic obstructive pulmonary disease (acute exacerbation), etc.
  • Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L after regular treatment).
  • Serious chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment (such as anti-infective drugs have been used for more than one week before the first administration and will continue to be used), including tuberculosis infection, etc.
  • Active HBV (HBsAg positive patients need to be tested for HBV DNA, which will be excluded if the HBV DNA is greater than the upper limit of the normal value) or HCV infection (patients with polymerase chain reaction (PCR) HCV RNA within the normal value range can participate in this study) or syphilis antibody positive (and confirmed) or HIV positive.
  • Rash on any part of the body and any disease that may cause skin reactions, such as cholestasis, systemic lupus erythematosus, eczema, allergic dermatitis, atopic dermatitis, herpes zoster, psoriasis, etc.
  • 6. Have the following previous medical history:
  • Major surgical operations (such as abdominal and thoracic major operations; excluding minor operations such as diagnostic puncture or infusion device implantation) have been performed within 28 days before the first administration of the study treatment, or major surgical treatment is expected to be required during the study period.
  • Serious cardio-cerebrovascular diseases occurred within 6 months before the first administration, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident (lacunar cerebral infarction without clinical significance can be included), etc.
  • 7. The following previous/concomitant drugs or therapies exist:
  • Those who use glucocorticoids or antihistamines or other drugs with therapeutic or preventive effects on rash within 2 weeks or 5 half-lives (whichever is longer) before the first administration.
  • Use of chemical small molecule antitumor drugs (including endocrine therapy) within 2 weeks or use of biological macromolecule anti-tumor, biological therapy, radiotherapy within 4 weeks before the first administration. Those who need to be treated with other anti-tumor drugs during the study.
  • Vaccinated within 4 weeks before the first administration or expected to be vaccinated during the observation period of study administration.
  • Those who are expected to undergo radiotherapy or hemodialysis within 2 months after the first administration.
  • 8. Patients who are pregnant, nursing or planning to become pregnant during the study.
  • 9. Other situations in which the investigator judged that the patient was not suitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qingyuan Zhang contact

86-13313612989

13313612989@163.com

China1 site

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Qingyuan Zhang, 86-13313612989, 13313612989@163.com

Other trials in China

About this study

Official title: A Single-arm Open-label Phase II Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011

The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011

Being tested
SYHX2011

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYHX2011Drug

    IV infusion, 260 mg/m^2

Study groups in NCT06354114
Study groupRoleWhat they receive
SYHX2011ExperimentalSubjects will be administrated with SYHX2011 once every 3 weeks.
Receives: Drug: SYHX2011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) by Investigator

    Measured: *Time Frame: Up to approximately 2 years

Secondary outcomes (3)

  1. Progression-Free-Survival (PFS)

    Measured: Up to approximately 2 years

  2. Time to progression (TTP)

    Measured: Up to approximately 2 years

  3. Incidence of adverse events

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06354114
Sponsor's protocol ID
SYHX2011-003
Status last verified
Apr 2024
First submitted
3 Apr 2024
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SYHX2011 in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd. 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 12 inclusion and 22 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: opening soon, as of the sponsor's last update on 9 Apr 2024. 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 Qingyuan Zhang (86-13313612989, 13313612989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) by Investigator (time frame: *Time Frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06354114.

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 9 Apr 2024.

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