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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05287308

Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: doxorubicin Drug: epirubicin Drug: pirarubicin Drug: cyclophosphamide Drug: albumin-bound paclitaxel Drug: paclitaxel Drug: docetaxel	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: AC followed by taxanes A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.	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: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: AC followed by taxanes

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

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: 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.

Outcome Measures

Primary Outcome Measures

5-year invasive disease-free survival (IDFS) rate [up to 60 months]
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause. 5-year IDFS rate is thepercentage of participants with IDFS from enrollment through 5 years.

Secondary Outcome Measures

IDFS [up to 60 months]
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause.
overall survival (OS) [up to 60 months]
OS was defined as the time from enrollment assignment to death as a result of any cause.
3-year invasive disease-free survival (IDFS) rate [up to 36 months]
3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.
Incidence and severity of adverse events [up to 60 months]
Adverse events as assessed by NCI-CTCAE V5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.