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Clinical Trials in China / NCT04136782
Recruiting Phase 4

Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer

NCT04136782 · tracked via the Priya Life Science China tracker
Sponsor
Shengjing Hospital
Phase
Phase 4
Started
2021-07-19
Last updated
2021-07-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Albumin-bound paclitaxel combined with carboplatinAll Albumin-Bound Paclitaxel trials (37) →All Carboplatin trials (591) →Epirubicin combined with docetaxelAll Epirubicin trials (50) →All Docetaxel trials (275) →

Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.

Epirubicin combined with docetaxel: Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.

Study summary

To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III; * estimated survival \> 3 months; * presence of clinically measurable lesions; * Karnofsky functional status score ≥ 70; * normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations; * age at 18-70 years. Exclusion Criteria: * stage IV breast cancer patients with bone metastasis or other distant metastasis; * severe renal insufficiency; * older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy; * those who have received antineoplastic therapy; * those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy; * those with history of other malignant tumors; * those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens; * those with mental and nervous system diseases who cannot comply with treatment; * those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy; * pregnant or lactating women; * those who are participating in other trials.

Primary outcome measure(s)

  • Pathologic complete remission rate — 5 years after treatment
    Pathologic complete remission will be evaluated 5 years after treatment according to the regression of tumors. Tumor regression will be assessed according to RECIST 1.1. Complete remission (CR)

Trial sites (7)

FacilityCityRegionStatus
Cancer Hospital Affiliated to Harbin Medical University Harbin Heilongjiang Recruiting
The Second Hospital of Jilin University Changchun Jilin Recruiting
Dalian Municipal Central Hospital Dalian Liaoning Recruiting
Panjin Liaohe Oilfield Gem Flower Hospital Panjin Liaoning Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
The Fourth Affiliated Hospital of China Medical University Shenyang Liaoning Recruiting
Liaoning Cancer Hospital & Institute Shenyang Liaoning Recruiting

More Shengjing Hospital trials in China

Psychological Screening and Nursing of Twin Pregnancy Recruiting
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer Recruiting
Axillary Lymph Node Treatment Guided by Naocarbon Tracing After Neoadjuvant Chemotherapy Recruiting
3D MRE-Based Evaluation of Meningioma Mechanical Properties and Histological Features Recruiting
Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI Starting soon

Other trials for the same condition

Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer Recruiting
Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy Recruiting
A Study on Predicting the Risk of Distant Metastasis in Breast Cancer Using AI-Generated Spatial Pathological Maps Recruiting
Research on the Development and Validation of Personalized Exercise Prescription System for Breast Cancer Patients Based on Large Language Models Starting soon
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04136782 on ClinicalTrials.gov ↗ ← All trials in China