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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: doxorubicin; Drug: epirubicin; Drug: pirarubicin; Drug: cyclophosphamide; Drug: albumin-bound paclitaxel; Drug: paclitaxel; Drug: docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiao LI, MD; Phone Number: 86-10-87788120; Email: liqiaopumc@yahoo.cn
• Study Contact Backup: Name: Binghe Xu, PHD; Phone Number: 86-10-87788495; Email: xubinghe@medmail.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, ChineseAMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year invasive disease-free survival (IDFS) rate	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.	up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IDFS	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.	up to 60 months
overall survival (OS)	OS was defined as the time from enrollment assignment to death as a result of any cause.	up to 60 months
3-year invasive disease-free survival (IDFS) rate	3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.	up to 36 months
Incidence and severity of adverse events	Adverse events as assessed by NCI-CTCAE V5.0	up to 60 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): September 1, 2027
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Paclitaxel; Epirubicin; Albumin-Bound Paclitaxel; Doxorubicin; Pirarubicin
• Other Study ID Numbers: LQ009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No