Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06765590

Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer

Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2026-03-09

24

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

Sponsors

S

Sichuan Huiyu Pharmaceutical Co., Ltd

Lead Sponsor

T

The First Hospital of Jilin University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Diagnosed breast cancer confirmed by histopathology or cytology
  • Metastatic breast cancer unresponsive to combination chemotherapy or recurrent breast cancer within 6 months after adjuvant chemotherapy
  • Candidates for albumin-bound paclitaxel treatment based on guidelines
  • Age 18 to 75 years, male or female
  • Body mass index (BMI) of 17 or higher
  • ECOG performance status score between 0 and 2
  • Expected survival time of 3 months or more
  • Use of effective non-drug contraception during the study and for 6 months after last dose
  • Lab results meeting thresholds for hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine clearance, and INR
  • Ability to communicate effectively and comply with study requirements
Not Eligible

You will not qualify if you...

  • Known allergy to paclitaxel, albumin, or excipients, excluding mild seasonal allergies
  • Treatment with radiotherapy, chemotherapy, immunotherapy, or endocrinotherapy within 4 weeks before study drug and still responding
  • Serious illnesses of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immune, skin, musculoskeletal, nervous, or psychiatric systems within 3 months prior to screening
  • Major surgery or fractures within 4 weeks before screening or planned during study
  • Use of other investigational drugs within 4 weeks before study
  • Use of CYP2C8 or CYP3A4 enzyme modifiers within 4 weeks before dosing or failure to suspend such medications
  • Consumption of certain foods (grapefruit, pomelo, mango), vigorous exercise, or other factors affecting drug metabolism within 48 hours before dosing
  • Use of granulocyte colony-stimulating factor therapy within 2 weeks before screening
  • Grade 2 or higher sensory or peripheral neuropathy at screening
  • Recent serious cardiac events or severe heart failure
  • Poorly controlled hypertension
  • Bleeding disorders or recent blood loss of more than 400 mL
  • Significant ECG abnormalities
  • History of alcohol or drug abuse, heavy smoking, or inability to refrain during study
  • Positive tests for hepatitis B, hepatitis C, HIV, syphilis
  • Pregnant or breastfeeding women
  • Other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated hospital of Hennan University of Science & Technology

Luoyang, Henan, China, 471003

Actively Recruiting

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Research Team

C

Chun Wan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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