Status:
ACTIVE_NOT_RECRUITING
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
Lead Sponsor:
RenJi Hospital
Conditions:
Tubular Breast Cancer
Mucinous Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. In patients ...
Detailed Description
In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status....
Eligibility Criteria
Inclusion
- Women aged ≥18years and ≤70 years;
- At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0;
- ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as \>1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals \>2.0 or HER2 gene copy \>6.0.
- No prior systemic or loco-regional treatment of breast cancer;
- Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
- No obvious main organs dysfunction.
Exclusion
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
- Patient is pregnant or breast feeding;
- Inflammatory breast cancer and metastatic breast cancer;
- Any evidence of sense or motor nerve disorders;
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
- Any concurrent malignancy other than breast cancer;
- Know severe hypersensitivity to any drugs in this study.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02221999
Start Date
September 1 2013
End Date
January 1 2029
Last Update
August 29 2023
Active Locations (12)
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1
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
Shenzhen, Guangdong, China
2
HanDan Central Hospital
Handan, Hebei, China, 056001
3
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
4
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
Hohhot, Inner Mongolia, China