Status:
RECRUITING
Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT
Lead Sponsor:
Shengjing Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
Triple-negative breast cancer (TNBC) accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug targe...
Detailed Description
Breast cancer has been one of the most common malignant tumors with highest morbidity and mortality that threatens women's health worldwide. Among US women, there were 250,000 new invasive breast canc...
Eligibility Criteria
Inclusion
- breast cancer is confirmed by the mammography, and the immunohistochemical results of cancer tissues are negative for estrogen receptor, progesterone receptor and anti-human epidermal growth factor receptor 2;
- positive for axillary lymph node metastasis;
- 18-70 years of age, female;
- patients have good compliance with the planned treatment, who are volunteer to participate in the study, are willing to be treated with solvent-based paclitaxel or nab-P at random, and provide written informed consent with the premise of fully understanding the study protocol.
Exclusion
- pregnant and lactating women;
- distant metastasis;
- patients with a history of other cancers or who have received radiotherapy on the chest;
- abnormalities in blood tests or presence of other symptoms of infection;
- allergy to paclitaxel;
- patients who have psychotropic drug abuse until now or those with a history of mental disorders;
- abnormalities in important organs such as the heart, lung, liver and kidney;
- patients who have participated in other clinical trials.
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
1498 Patients enrolled
Trial Details
Trial ID
NCT04137653
Start Date
July 19 2021
End Date
November 30 2026
Last Update
July 20 2021
Active Locations (1)
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1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004