Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
NCT05287308 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2022-03-31
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
Interventions
- 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 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.
- DRUG
-
paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
- DRUG
-
docetaxel 80\~100mg/m2, i.v., d1, q3w.
Sponsors & Collaborators
-
CSPC Ouyi Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- China
Study Locations
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