Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 5-year invasive disease-free survival (IDFS) rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AC followed by albumin-bound paclitaxel
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.
干预措施: doxorubicin (Drug)
AC followed by albumin-bound paclitaxel
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.
干预措施: epirubicin (Drug)
AC followed by albumin-bound paclitaxel
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.
干预措施: pirarubicin (Drug)
AC followed by albumin-bound paclitaxel
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.
干预措施: cyclophosphamide (Drug)
AC followed by albumin-bound paclitaxel
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.
干预措施: albumin-bound paclitaxel (Drug)
AC followed by taxanes
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
干预措施: doxorubicin (Drug)
AC followed by taxanes
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
干预措施: epirubicin (Drug)
AC followed by taxanes
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
干预措施: pirarubicin (Drug)
AC followed by taxanes
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
干预措施: cyclophosphamide (Drug)
AC followed by taxanes
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
干预措施: paclitaxel (Drug)
AC followed by taxanes
A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
干预措施: docetaxel (Drug)
结局指标
主要结局
5-year invasive disease-free survival (IDFS) rate
时间窗: up to 60 months
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. 5-year IDFS rate is thepercentage of participants with IDFS from enrollment through 5 years.
次要结局
- IDFS(up to 60 months)
- overall survival (OS)(up to 60 months)
- 3-year invasive disease-free survival (IDFS) rate(up to 36 months)
- Incidence and severity of adverse events(up to 60 months)
研究者
Binghe Xu
Academician，Director of Department of Clinical Trial Center
Chinese Academy of Medical Sciences