AzTrials
AzTrials

Advanced Breast CancerPhase 3NCT05753865

A Study to Evaluate the Efficacy and Safety in Patients With Advanced Breast Cancer Treated With SYHX2011 Compared to Paclitaxel for Injection (Albumin-bound)

A Phase 3 study testing SYHX2011 and Paclitaxel for injection (albumin-bound) in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate the efficacy and safety in patients with advanced breast cancer treated with SYHX2011 versus paclitaxel for injection (albumin-bound). 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 and Paclitaxel for injection (albumin-bound)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
454 participants
Where
1 siteChina
Study dates
1 May 2023to 1 Sep 2024
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Voluntarily sign the written informed consent.
  • 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 investigators judge the breast cancer patients who are suitable for anti-tumor treatment with paclitaxel for injection (albumin-bound) alone.
  • According to RECIST 1.1 standard, there is at least one measurable focus. For the lesions that have been treated with radiotherapy in the past, the lesions can be included in the measurable lesions only if the disease progression is clear after radiotherapy.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before the first administration.
Show all 12Show fewer
  • Expected survival time ≥3 months.
  • 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.
  • 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

  • History of severe allergy or major hypersensitivity to paclitaxel or human serum albumin (NCI-CTCAE Version 5.0, ≥ Level 3).
  • 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.
  • Patients with active brain metastasis without treatment (including symptomatic brain metastasis or meningeal metastasis); If the brain metastasis of the patient has been treated and the condition of the metastasis is stable (the brain imaging examination at least 4 weeks before the first administration shows that the lesion is stable, and there is no new nervous system symptom, or the nervous system symptom has returned to the baseline level, and there is no need for hormone treatment at least 14 days before the first administration of the investigational treatment), and there is no evidence of new or original brain metastasis enlargement, the patient is allowed to be enrolled.
  • 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.
  • 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 (excluding stable ones with systolic blood pressure>150 mmHg and/or diastolic blood pressure>90 mmHg after stable treatment), etc.
Show all 22Show fewer
  • There are clear 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 stable 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.
  • 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.
  • 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.
  • 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 study administration.
  • Those who are expected to undergo radiotherapy or hemodialysis within 2 months after the first administration.
  • Patients who are pregnant, nursing or planning to become pregnant during the study.
  • 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.

China1 site

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Cuizhi Geng, 86-0311-66696233, hb4thgcp@126.com

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind Phase Ш Study to Evaluate the Efficacy and Safety in Patients With Advanced Breast Cancer Treated With SYHX2011 Compared to Paclitaxel for Injection (Albumin-bound)

The main purpose of this study is to evaluate the efficacy and safety in patients with advanced breast cancer treated with SYHX2011 versus paclitaxel for injection (albumin-bound).

Being tested
SYHX2011, Paclitaxel for injection (albumin-bound)

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

  • Paclitaxel for injection (albumin-bound)Drug

    IV infusion, 260 mg/m^2

Study groups in NCT05753865
Study groupRoleWhat they receive
SYHX2011ExperimentalPatients will be administrated with SYHX2011 once every 3 weeks.
Receives: Drug: SYHX2011
Paclitaxel for injection (albumin-bound)Active comparatorPatients will be administrated with paclitaxel for injection (albumin-bound) once every 3 weeks.
Receives: Drug: Paclitaxel for injection (albumin-bound)

What is being measured

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

  1. Objective Response Rate (ORR) by IRC

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. ORR by investigator

    Measured: Up to approximately 2 years

  2. Progression-Free-Survival (PFS)

    Measured: Up to approximately 2 years

  3. Time to progression (TTP)

    Measured: Up to approximately 2 years

  4. Overall survival (OS)

    Measured: Up to approximately 2 years

  5. 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 posted3 Mar 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 2024 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753865
Sponsor's protocol ID
SYHX2011-002
Status last verified
Feb 2023
First submitted
22 Feb 2023
Last updated
3 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang L, Wang J, Sun T, Li F, Zhao B, Han G, Tong Z, Yang H, Yin Y, Kong X, Wang Y, Nie J, Ma L, Zhang Y, Luo J, Shan C, Yao J, Tan S, Ling X, Sun H, Li H, Ma L, Zhou T, Liu Y, Qi Y, Song Z, Li Y, Yang C, Hui T, Wang M, Wang H, Zhang X, Zhao W, Li Y, Li M, Xin Y, Luo X, Yin D, Luo H, Liu H, Lu Q, Yuan J, Zhang Q, Geng C. Albumin-Bound Paclitaxel (SYHX2011) in Patients with Advanced Breast Cancer: A Multicenter, Randomized, Double-Blind, Phase III Study. Cancer Commun (Lond). 2026 Jun 26;46:0037. doi: 10.34133/cancomm.0037. eCollection 2026.

    PubMed 42368972

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYHX2011 and Paclitaxel for injection (albumin-bound) 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) by IRC (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 NCT05753865, which also lists 1 linked publication.

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 3 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in