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

Overview

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.

Interventions

• Drug doxorubicin
  doxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.
• Drug epirubicin
  epirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.
• Drug pirarubicin
  pirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.
• Drug cyclophosphamide
  cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.
• Drug albumin-bound paclitaxel
  albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.
• Drug paclitaxel
  paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
• Drug docetaxel
  docetaxel 80\~100mg/m2, i.v., d1, q3w.

Primary outcome measures

• 5-year invasive disease-free survival (IDFS) rate [Time frame: up to 60 months]

Secondary outcome measures (4)

• IDFS [Time frame: up to 60 months]
• overall survival (OS) [Time frame: up to 60 months]
• 3-year invasive disease-free survival (IDFS) rate [Time frame: up to 36 months]
• Incidence and severity of adverse events [Time frame: up to 60 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Cancer Hospital, ChineseAMS — Beijing

Identifiers

NCT: NCT05287308 · LQ009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗