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NCT Number: NCT05287308

Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a 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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxorubicin

Drug

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

Epirubicin

Drug

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

pirarubicin

Drug

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

Cyclophosphamide

Drug

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

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.

paclitaxel

Drug

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

docetaxel

Drug

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

Primary outcomes

  1. 5-year invasive disease-free survival (IDFS) rate

    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.

Secondary outcomes

  1. IDFS

    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.

  2. overall survival (OS)

    Time frame: up to 60 months

    OS was defined as the time from enrollment assignment to death as a result of any cause.

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

    Time frame: up to 36 months

    3-year IDFS rate is the percentage of participants with IDFS from enrollment through 3 years.

  4. Incidence and severity of adverse events

    Time frame: up to 60 months

    Adverse events as assessed by NCI-CTCAE V5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Binghe Xu, PHD

CONTACT

[email protected]

86-10-87788495

Qiao Li, MD

CONTACT

[email protected]

86-10-87788120

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2022
Registry last updated
Mar 31, 2022

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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