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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChinese Academy of Medical Sciences

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • doxorubicin
  • epirubicin
  • pirarubicin
  • cyclophosphamide
  • albumin-bound paclitaxel
  • paclitaxel
  • docetaxel

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chinese Academy of Medical Sciences

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborator