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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Drug: epirubicin; Drug: doxorubicin; Drug: docetaxel; Drug: paclitaxel; Drug: pirarubicin; Drug: albumin-bound paclitaxel; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05287308

LQ009

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

AC followed by albumin-bound paclitaxel

Experimental group

Description:

A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.

Treatment:

Drug: cyclophosphamide

Drug: albumin-bound paclitaxel

Drug: pirarubicin

Drug: doxorubicin

Drug: epirubicin

AC followed by taxanes

Active Comparator group

Description:

A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.

Treatment:

Drug: paclitaxel

Drug: cyclophosphamide

Drug: pirarubicin

Drug: doxorubicin

Drug: docetaxel

Drug: epirubicin