Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Paclitaxel; Pirarubicin

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.