Clinical trial NCT05287308: Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
Official title: Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2022-03-18
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Female patients aged from 18 to 70 years old;
2. Histologically confirmed as invasive breast cancer;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;
5. AC-T adjuvant chemotherapy is planned after breast cancer surgery;
6. 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;
7. LVEF ≥ 50%;
8. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.

Exclusion Criteria:

1. 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;
2. Participants who have received prior any systematic treatment for breast cancer;
3. Participants with bilateral invasive breast cancer;
4. Breast cancer with distant metastasis;
5. Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;
6. 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;
7. Previous or current existence of other malignant tumors other than breast cancer;
8. Severe liver and kidney dysfunction;
9. The presence of any myelodysplastic and other hematopoietic disorders;
10. Participants who are known to be allergic to the active or other components of the study treatment;
11. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
12. Participants who were judged by the investigator to be unsuitable for this study.

Primary outcomes:
measure: 5-year invasive disease-free survival (IDFS) rate
timeFrame: up to 60 months
Secondary outcomes:
measure: IDFS
timeFrame: up to 60 months
measure: overall survival (OS)
timeFrame: up to 60 months
measure: 3-year invasive disease-free survival (IDFS) rate
timeFrame: up to 36 months
measure: Incidence and severity of adverse events
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, ChineseAMS
state: Beijing
Study officials:
References: