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

NCT ID: NCT05287308

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2027-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AC followed by albumin-bound paclitaxel

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

Group Type: EXPERIMENTAL

doxorubicin

Intervention Type: DRUG

doxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.

epirubicin

Intervention Type: DRUG

epirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.

pirarubicin

Intervention Type: DRUG

pirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.

cyclophosphamide

Intervention Type: DRUG

cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.

albumin-bound paclitaxel

Intervention Type: DRUG

albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.

AC followed by taxanes

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

Group Type: ACTIVE_COMPARATOR

doxorubicin

Intervention Type: DRUG

doxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.

epirubicin

Intervention Type: DRUG

epirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.

pirarubicin

Intervention Type: DRUG

pirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.

cyclophosphamide

Intervention Type: DRUG

cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.

paclitaxel

Intervention Type: DRUG

paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.

docetaxel

Intervention Type: DRUG

docetaxel 80\~100mg/m2, i.v., d1, q3w.

Interventions

doxorubicin

doxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.

Intervention Type: DRUG

epirubicin

epirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.

Intervention Type: DRUG

pirarubicin

pirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.

Intervention Type: DRUG

cyclophosphamide

cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.

Intervention Type: 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.

Intervention Type: DRUG

paclitaxel

paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.

Intervention Type: DRUG

docetaxel

docetaxel 80\~100mg/m2, i.v., d1, q3w.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Binghe Xu

Academician，Director of Department of Clinical Trial Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Qiao Li, MD

Role: CONTACT

liqiaopumc@yahoo.cn

86-10-87788120

Binghe Xu, PHD

Role: CONTACT

xubinghe@medmail.com.cn

86-10-87788495

Other Identifiers

LQ009

Identifier Type: -

Identifier Source: org_study_id