Status:
NOT_YET_RECRUITING
Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.
Eligibility Criteria
Inclusion
- Female patients aged from 18 to 70 years old;
- Histologically confirmed as invasive breast cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;
- AC-T adjuvant chemotherapy is planned after breast cancer surgery;
- Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence \[such as high Ki67 expression (≥20%), T \> 2 cm, age \< 35 years, lymphovascular invasion, grade 3 histology\]; 2) HR negative with positive lymph node or T \> 2 cm;
- LVEF ≥ 50%;
- Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
Exclusion
- In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \> 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[Mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure \> 180mm Hg or diastolic blood pressure \> 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
- Participants who have received prior any systematic treatment for breast cancer;
- Participants with bilateral invasive breast cancer;
- Breast cancer with distant metastasis;
- Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;
- Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active peptic ulcer, unstable diabetes;
- Previous or current existence of other malignant tumors other than breast cancer;
- Severe liver and kidney dysfunction;
- The presence of any myelodysplastic and other hematopoietic disorders;
- Participants who are known to be allergic to the active or other components of the study treatment;
- Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
- Participants who were judged by the investigator to be unsuitable for this study.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05287308
Start Date
March 1 2022
End Date
September 1 2027
Last Update
March 31 2022
Active Locations (1)
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1
Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, China, 100021