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

NCT05287308 | Not Yet Recruiting

• 1 other identifier: LQ009
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• IDFS

  up to 60 months

• overall survival (OS)

  up to 60 months

• 3-year invasive disease-free survival (IDFS) rate

  up to 36 months

• Incidence and severity of adverse events

  up to 60 months

Study Arms (2)

AC followed by albumin-bound paclitaxel

EXPERIMENTAL

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

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

AC followed by taxanes

ACTIVE COMPARATOR

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

Drug: doxorubicin; Drug: epirubicin; Drug: pirarubicin; Drug: cyclophosphamide; Drug: paclitaxel; Drug: docetaxel

Interventions

doxorubicin DRUG

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

AC followed by albumin-bound paclitaxel; AC followed by taxanes

epirubicin DRUG

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

AC followed by albumin-bound paclitaxel; AC followed by taxanes

pirarubicin DRUG

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

AC followed by albumin-bound paclitaxel; AC followed by taxanes

cyclophosphamide DRUG

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

AC followed by albumin-bound paclitaxel; AC followed by taxanes

albumin-bound paclitaxel 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 albumin-bound paclitaxel

paclitaxel DRUG

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

AC followed by taxanes

docetaxel DRUG

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

AC followed by taxanes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Epirubicin; pirarubicin; Cyclophosphamide; Albumin-Bound Paclitaxel; Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Qiao Li, MD

CONTACT

86-10-87788120; liqiaopumc@yahoo.cn

Binghe Xu, PHD

CONTACT

86-10-87788495; xubinghe@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician，Director of Department of Clinical Trial Center

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)