Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, 100021, China
NCT Number: NCT05287308
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.
Trial opening soon.
Get Notified18 year–70 year
Female
Interventional
Not applicable
Beijing, Beijing Municipality, 100021, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
doxorubicin 50~60mg/m2, i.v., d1, q3w or q2w.
epirubicin 80~100mg/m2, i.v., d1, q3w or q2w.
pirarubicin 40~50mg/m2, i.v., d1, q3w or q2w.
cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.
albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.
paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
docetaxel 80~100mg/m2, i.v., d1, q3w.
Time frame: 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.
Time frame: 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.
Time frame: up to 60 months
OS was defined as the time from enrollment assignment to death as a result of any cause.
Time frame: up to 36 months
3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.
Time frame: up to 60 months
Adverse events as assessed by NCI-CTCAE V5.0
Contact information is provided by the study sponsor or research team.
Binghe Xu, PHD
CONTACT
Qiao Li, MD
CONTACT
Chinese Academy of Medical Sciences
Other
Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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