Breast CancerNCT06765590
Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer
A study testing T, 260 mg/m2, paclitaxel for injection (albumin-bound) and R, 260 mg/m2, paclitaxel for injection (albumin bound). in people with Breast Cancer, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- T, 260 mg/m2, paclitaxel for injection (albumin-bound) and R, 260 mg/m2, 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to 30 Dec 2026
- Phase
- Interventional
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in the study and sign the informed consent forms (ICFs);
- Patients with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ① with metastatic breast cancer that does not respond to combination chemotherapy or recurrent breast cancer within 6 months after adjuvant chemotherapy, and an anthracycline anticancer drug should be used in the previous chemotherapy unless clinically contraindicated; ② investigators determine that subjects are candidates for albumin-bound paclitaxel by reference to the treatment guidelines (NCCN Guidelines and CSCO Guidelines for breast cancer);
- Aged 18-75 years old (both inclusive), males or females; body mass index (BMI) ≥17 (BMI = weight (kg)/height (m2));
- The ECOG score is 0-2;
- The expected survival time is ≥3 months;
- Subjects have no plans to become pregnant and voluntarily use non-pharmacologic contraception (such as total abstinence, condom, contraceptive ring, vasectomy, etc.) or other highly effective contraceptive methods, and have no plans to donate eggs or sperm throughout the trial and within 6 months after the last dose;
- Subjects with the laboratory test results as follows: hemoglobin (Hb) ≥80 g/L (no blood transfusion within 14 days), absolute neutrophil count (ANC) ≥1.5 * 109/L, platelet count (PLT) ≥100 * 109/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal value (for patients without liver metastasis) or ≤5 times the upper limit of normal value (for patients with liver metastasis); total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (for patients without liver metastasis) or ≤3 times the upper limit of normal value (for patients with liver metastasis); serum creatinine clearance ≥60 mL/min [formula: Ccr: (140 - age) * body weight (kg) * 0.85 (if female)/0.818 * Scr (μmol/L)]; international normalized ratio (INR) ≤1.5 times the upper limit of normal value;
- Subjects are able to communicate well with the investigator and understand and comply with the requirements of the study.
Who cannot join
- Subjects with allergic constitution (excluding mild asymptomatic seasonal allergies), or who are known (or suspected) to be allergic to or have a specific reaction to the active ingredient paclitaxel or excipients, albumin;
- Subjects who have received radiotherapy, chemotherapy, immunotherapy and endocrinotherapy within 4 weeks before the administration of the investigational drug and still respond to the treatment;
- Subjects who have suffered from serious illness of cardio-cerebral vascular system, lung, liver, kidney, gastrointestinal tract, endocrine system, immune system, skin, musculoskeletal system and nervous system or psychiatric disorders within 3 months before screening and are considered unsuitable for enrollment by the investigator;
- Subjects who have undergone major surgery or suffered from fracture within 4 weeks prior to screening, or plan to undergo major surgery during the study;
- Subjects who have received treatment with other investigational drugs within 4 weeks before the study;
- Subjects who have used substrates, inducers or inhibitors of CYP2C8 or CYP3A4 enzymes (including but not limited to ketoconazole and other imidazole antifungal agents, verapamil, diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17-α diethylstilbestrol, retinoic acid, quercetin, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine, etc.) in concomitant medications within 4 weeks prior to the first dose of the investigational drug or fail to suspend medications during the study (except for stable dosing at steady state, i.e. the dosing regimen remains unchanged);
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- Subjects who have consumed special diet (foods that affect the activity of CYP3A4 or CYP2C8 enzyme, such as grapefruit, pomelo, mango, etc.), exercised vigorously or with other factors that may affect drug absorption, distribution, metabolism and excretion within 48 hours before the administration of the investigational drug;
- Subjects who have received therapy with the granulocyte colony-stimulating factor (G-CSF) within 2 weeks before screening;
- Subjects with grade 2 or higher sensory neuropathy/peripheral neuropathy at screening;
- Subjects who have experienced myocardial infarction (within 6 months before the study), severe or unstable angina, and grade III-IV heart failure according to the New York Heart Association (NYHA) Classification, or underwent coronary or peripheral artery bypass grafting;
- Subjects with poorly controlled hypertension (with the systolic blood pressure of >160 mmHg and/or diastolic blood pressure of >100 mmHg under regular medication);
- Subjects who have bleeding tendency or are receiving thrombolytic or anticoagulant therapy or have donated or lost more than 400 mL of blood within 3 months before the administration of the investigational drug;
- Subjects with clinically significant 12-lead ECG abnormalities, who are considered unsuitable for enrollment by the investigator;
- Subjects with a history of alcohol (drinking more than 14 units of alcohol per week within 6 months prior to the first dose: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), drug abuse (using narcotic drugs or psychotropic drugs for non-medical purposes) or addiction to drugs, who smoked more than 5 cigarettes per day within 3 months prior to screening, or who could not stop smoking or drinking during the period from signing the ICFs to completing the bioequivalence study;
- Subjects with positive results of hepatitis B surface antigen (HBsAg), HBV DNA, hepatitis C core antibody (HCV-cAg), HCV RNA, HIV antibody, treponema pallidum antibody, or rapid plasma reagin (RPR) test;
- Pregnant or lactating women;
- Other conditions judged inappropriate for participation 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
The First Affiliated hospital of Hennan University of Science & Technology
Luoyang, Henan, 471003
Caie Wang, 245454618@qq.com
About this study
Official title: A Randomized, Open-label, Single-dose, Two-period, Two-way Crossover Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer
This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.
Read the detailed description
This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.
- Conditions
- Breast Cancer
- Being tested
- T, 260 mg/m2, paclitaxel for injection (albumin-bound), R, 260 mg/m2, paclitaxel for injection (albumin bound).
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T, 260 mg/m2, paclitaxel for injection (albumin-bound)Drug
T, 260 mg/m2, paclitaxel for injection (albumin-bound)
R, 260 mg/m2, paclitaxel for injection (albumin bound).Drug
R, 260 mg/m2, paclitaxel for injection (albumin bound).
| Study group | Role | What they receive |
|---|---|---|
| Test preparation T: Paclitaxel for injection (albumin-bound) | Experimental | Not described Receives: Drug: T, 260 mg/m2, paclitaxel for injection (albumin-bound) |
| Reference Preparation R: Paclitaxel (albumin-bound) for injection (Trade name: ABRAXANE) | Experimental | Not described Receives: Drug: R, 260 mg/m2, paclitaxel for injection (albumin bound). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of paclitaxel (Cmax)
Measured: Predose: 0 hours; Post-infusion: 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours.
Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf)
Measured: Predose: 0 hours; Post-infusion: 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours.
Area under the concentration-time curve from time zero to the last time of paclitaxel (AUC 0-t)
Measured: Predose: 0 hours; Post-infusion: 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start12 Mar 2025
- Primary completion10 Feb 2026
- Study completion30 Dec 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University, The First Affiliated Hospital of Bengbu Medical University, Chongqing Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Qianfoshan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765590
- Sponsor's protocol ID
- HY-PA023-001
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No