Phase
Condition
Breast Cancer
Cancer
Treatment
Docetaxel
Cyclophosphamide
Clinical Study ID
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- women aged 18-70 years old;
- Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, and isER+/HER2- confirmed by histopathology after early breast cancer surgery(HER2-negativebreast cancer (based on most recently analyzed biopsy) defined as a negative in situhybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH),Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH))test is required by local laboratory testing.), with at least one of the followingconditions: (1) histological grade III; (2) Ki67 ≥ 30%; (3) progesterone receptor (PR) ≤ 20% positive; (4) age less than 35 years; (5) extensive vascular tumor thrombus; (6)multigene detection recurrence score (RS) >25;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has adequate organ function meeting the following criteria: (1) adequate bone marrowfunction: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absoluteneutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver andkidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN),Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serumcreatinine ≤ 1×ULN,and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
- Participants voluntarily joined the study, has signed informed consent before anytrial related activities are conducted, has good compliance and has agreed tofollow-up.
Exclusion
Exclusion Criteria:
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapyor endocrine therapy);
- Has bilateral breast cancer;
- Has previous history of additional malignancy, with the exception of adequatelytreated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, andinflammatory breast cancer);
- Is pregnant, is breast feeding women, or women of childbearing age who cannot practiceeffective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, leftventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardiocerebral vascular disease within the 6 months previous of randomization (such asunstable angina, chronic heart failure, uncontrolled hypertension with bloodpressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabeticpatients with poor blood glucose control; patients with severe hypertension;
- Has known allergy to taxane and excipients.
- Has severe or uncontrolled infection;
- Has a history of psychotropic substance abuse and were unable to abandon drug habits,or those with history of mental disorders;
- the researchers judged patients to be unsuitable for the study.
Study Design
Study Description
Connect with a study center
Chongqing Cancer Hospital
Chongqing, Chongqing 400030
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
Sun Yet-Sen Memorial Hospital, Sun Yet-Sen University
Guangzhou, Guangdong 510120
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150081
ChinaActive - Recruiting
The First Bethune Hospital of Jilin University (The First Hospital of Jilin University)
Changchun, Jilin 130021
ChinaActive - Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning 116027
ChinaActive - Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning 110001
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266000
ChinaActive - Recruiting
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting
OB/GYN Hospital of Fudan University
Shanghai, Shanghai 200011
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300052
ChinaActive - Recruiting
The First Affiliated Hospital, ZheJiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
ChinaActive - Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, Zhejiang 310009
ChinaActive - Recruiting
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